... [Federal Register: April 19, 2010 (Volume 75, Number 74 )] [Notices] [Page 20429-20437] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID: fr19ap10-115] [[ Page 20429 ]]-Part II Department of Health and Human Services-Food and Drug Administration-Amended Authorizations of Emergency Use of Zanamivir, Oseltamivir Phosphate, and Peramivir; Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability; Notices [[ Page 20430 ]]-DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0276] Amended Authorizations of Emergency Use of Certain Antiviral Drugs Zanamivir and Oseltamivir Phosphate; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice.-SUMMARY: The Food and Drug Administration (FDA) is announcing amendments to the two Emergency Use Authorizations (EUAs) (the Authorizations) for certain products from the neuraminidase class of antivirals, zanamivir and oseltamivir phosphate, issued on April 27, 2009, under the Federal Food, Drug, and Cosmetic Act (the act ), as requested ...

... vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb-3 (a). The then Acting Secretary also specified that these declarations are declarations of emergency as defined by former Secretary Michael O. Leavitt in the October 10, 2008 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Influenza Antivirals Oseltamivir Phosphate and Zanamavir, as amended, and the December 17, 2008 Declaration under the PREP Act for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices. The Secretary renewed the then Acting Secretary's determination that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009 H1N1 Influenza) on July 24, October 1, and December 28, 2009, and March 26, 2010. Also on March 26, 2010, the Secretary renewed the then Acting Secretary's declarations of emergency justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal ...