content/pkg/FR-/pdf/2020-06222.pdf), FDA announced general procedures for making available FDA guidances related to the COVID-19 PHE. Since the start of the COVID-19 pandemic in 2020, FDA has issued more than 80 COVID-19-related guidances (not including revisions). (HHS, Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap (February 9, 2023), available at On February 9, based on current COVID-19 trends, HHS announced that it is planning for the declaration to expire at the end of the day on May 11, 2023. On February 9, 2023, the Secretary of HHS renewed the COVID-19 PHE declaration, effective February 11, 2023. 247d), determined that a PHE existed (COVID-19 PHE) and had existed since January 27, 2020, nationwide. On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, the prior Secretary of HHS, pursuant to the authority under section 319 of the PHS Act ( 42 U.S.C. End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: I. 1C001, HFS-024, Food and Drug Administration, College Park, MD 20740, 24 Diane Heinz, Center for Veterinary Medicine (CVM), Food and Drug Administration, 7500 Standish Pl., HFV-6, Rockville, MD 20855, 24 Amanda Wulf, Office of Regulatory Affairs (ORA), Food and Drug Administration, 12420 Parklawn Dr., ELEM-4044, Rockville, MD 20857, 30. 6282, Silver Spring, MD 20993-0002, 30 Philip Chao, Center for Food Safety and Applied Nutrition (CFSAN), CPK1 Rm. 5456, Silver Spring, MD 20993-0002, 30 Kimberly Thomas, Center for Drug Evaluation and Research, Food and Drug Administration (CDER), 10903 New Hampshire Ave., Bldg. 7301, Silver Spring, MD 20993-0002, 24 Erica Takai, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Start Further Info FOR FURTHER INFORMATION CONTACT:ĭiane Maloney, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. This notice is intended to provide clarity to stakeholders with respect to the guidance documents that will no longer be effective with the expiration of the PHE declaration and the guidances that FDA is revising to continue in effect after the expiration of the PHE declaration. Many of those guidance documents are tied to the duration of the PHE declaration. The Food and Drug Administration (FDA, Agency, or we) has issued guidance documents to address the circumstances of the public health emergency and, more generally, COVID-19. The declaration is expected to expire at the end of the day on May 11, 2023. On February 9, 2023, the Secretary of Health and Human Services (HHS) renewed the Coronavirus Disease 2019 (COVID-19) public health emergency declaration issued under section 319 of the Public Health Service Act (PHS Act) (“PHE declaration”), effective February 11, 2023. Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, HHS. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register.
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