Emergency Preparedness and Response

Emergency Use Authorization--Archived Information

This page is intended to provide reference information on EUAs that were issued during previous public health emergencies (which have ended) and on amendments to EUAs.  Learn more about EUAs and view a list of current EUAs on our main EUA page.

All EUAs listed on this page are NO LONGER IN EFFECT because they have been terminated.

Ebola Virus EUA – ARCHIVED INFORMATION 

View current EUA information related to Ebola, including EUAs noted below that have been reissued. All Ebola EUAs in the list below have been reissued, and have current counterparts.

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and LabelingEUA Determination and DeclarationPREP Act Declaration (if applicable)
DoD EZ1 Real-time RT-PCR Assay

August 5, 2014

(Note: This EUA was reissued in its entirety on October 10, 2014)

Authorization (PDF, 282 KB)FR notice

Heathcare (PDF, 97 KB)

Patients (PDF, 90 KB)

Labeling (PDF, 1.1 MB)

Declaration (still in effect) 
CDC Ebola Virus VP40 Real-time RT-PCR Assay

October 10, 2014

(Note: This EUA was reissued in its entirety on March 2, 2015)

Authorization (PDF, 57 KB)FR notice

Heathcare (PDF, 211 KB)

Patients (PDF, 123 KB)

Labeling (PDF, 474 KB)

Declaration (still in effect) 
CDC Ebola Virus NP Real-time RT-PCR Assay

October 10, 2014

(Note: This EUA was reissued in its entirety on March 2, 2015)

Authorization (PDF, 57 KB)FR notice

Heathcare (PDF, 193 KB)

Patients (PDF, 123 KB)

Labeling (PDF, 475 KB)

Declaration (still in effect) 
BioFire Defense LLC FilmArray NGDS BT-E Assay

October 25, 2014

(Note: This EUA was reissued in its entirety on March 2, 2015)

Authorization (PDF, 133 KB)FR notice

Heathcare (PDF, 42 KB)

Patients (PDF, 39 KB)

Labeling (PDF, 2.4 MB)

Declaration (still in effect) 
RealStar® Ebolavirus RT-PCR Kit 1.0

November 10, 2014

(Note: This EUA was reissued in its entirety on November 26, 2014)

Authorization (PDF, 256 KB)FR notice

Heathcare (PDF, 81 KB)

Patients (PDF, 92 KB)

Labeling (PDF, 645 KB)

Declaration (still in effect) 
ReEBOV™ Antigen Rapid Test

February 24, 2015 

(Note: This EUA was reissued in its entirety on March 16, 2015)

Authorization (PDF, 405 KB) 

Heathcare (PDF, 92 KB)

Patients (PDF, 90 KB)

Labeling (PDF, 478 KB)

Declaration (still in effect) 

back to list of archived EUAs

Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA – ARCHIVED INFORMATION

View current EUA information related to MERS-CoV

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheet and LabelingEUA Determination and DeclarationPREP Act Declaration (if applicable)
CDC Novel Coronavirus 2012 Real-time RT-PCR Assay

June 5, 2013
 

(Note: This EUA was reissued in its entirety on June 10, 2014 – current EUA)

(no archived documents)FR notice – NO LONGER IN EFFECT(no archived documents)Determination and Declaration – HHS (still in effect) (see Determination)
RealStar® MERS-CoV RT-PCR Kit U.S.

July 17, 2015 

 

(Note: This EUA was reissued in its entirety on  February 12, 2016 – current EUA)

(no archived documents)FR notice(no archived documents)Determination and Declaration – HHS (still in effect) (see Determination)

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H1N1 EUAs - ARCHIVED INFORMATION

Medical ProductDate of EUA IssuanceLetter of Authorization or Other EUA-Related Information
Antiviral Disposition: Oseltamivir (Tamiflu), Zanamivir (Relenza), and PeramivirJune 22, 2010

Authorization Disposition Letter and Question and Answer Attachment (June 22, 2010)

Tamiflu and Relenza Emergency Use Authorization Disposition Letters and Question and Answer Attachments (June 22, 2010)

Antivirals Various

Peramivir

Tamiflu

Relenza

In vitro diagnostics

VariousHistorical information about 2009 H1N1 Influenza EUAs for IVDs
Personal Protective Equipment (PPE)May 1, 2009 (PDF, 2 MB) Historical information about 2009 H1N1 Influenza EUAs for PPE

back to list of archived EUAs

Anthrax Vaccine Adsorbed (AVA) EUA - ARCHIVED INFORMATION

Medical ProductDate of EUA IssuanceLetter of Authorization or Other EUA-Related InformationFact SheetsEUA Determination and Declaration PREP Act Declaration (if applicable)
AVAJanuary 14, 2005

Determination and Declaration Regarding Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax (FR notice, February 2, 2005)

Extension (FR notice, August 3, 2005)

Termination (FR notice, February 1, 2006)

(no archived documents)Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax (FR notice, February 2, 2005)Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax (FR notice, February 2, 2005)

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Page Last Updated: 03/15/2016
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