Department of Health and Human Services October 5, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
No Sail Order and Suspension of Further Embarkation; Third Modification and Extension of No Sail Order and Other Measures Related to Operations
The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces a third modification and extension of the No Sail Order and Other Measures Related to Operations that was issued on July 16, 2020. This Order applies to cruise ships defined as commercial, non-cargo, passenger-carrying vessels with the capacity to carry 250 or more individuals (passengers and crew) and with an itinerary anticipating an overnight stay onboard or a 24-hour stay onboard for either passengers or crew, that are operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States. This Order shall additionally apply to cruise ships operating outside of U.S. waters if the cruise ship operator intends for the ship to return to operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States during the period that this Order is in effect.
Revocation of Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Antibodies Against SARS-CoV-2, the Virus That Causes Coronavirus Disease 2019 (COVID-19)
The Food and Drug Administration (FDA) is announcing the revocations of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Autobio Diagnostics Co. Ltd. (``Autobio'') for the Anti-SARS-CoV-2 Rapid Test (``Autobio's Test'') and to Manufacturers and Other Stakeholders (``Stakeholders'') for certain in vitro diagnostic SARS-CoV-2 Antibody Tests. FDA revoked Autobio's Authorization on August 6, 2020, and the Stakeholders' Authorization on July 21, 2020, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Agency Information Collection Activities: Submission to OMB for Review and Approval: Public Comment Request; Information Collection Request Title: Application for Deemed Health Center Program Award Recipients To Sponsor Volunteer Health Professionals for Deemed PHS Employment
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Postponement
The Food and Drug Administration (FDA) is postponing the meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee scheduled from October 7, 2020, to a later date to be determined. The meeting was announced in the Federal Register of August 20, 2020. A future meeting date will be announced in the Federal Register.
Requirements for Additional Traceability Records for Certain Foods; Proposed Rule; Public Meetings; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing three virtual public meetings entitled ``Requirements for Additional Traceability Records for Certain Foods; Proposed Rule.'' The purpose of the public meetings is to discuss the proposed rule entitled ``Requirements for Additional Traceability Records for Certain Foods,'' which was issued under the FDA Food Safety Modernization Act (FSMA). These public meetings are intended to facilitate and support the public's evaluation and commenting process on the proposed rule.
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