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2015-03-17
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Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability
Notices
D09002ee18e29df51
D09002ee18e29dffb
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus in response to the 2014 Ebola virus outbreak in West Africa. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. (Roche). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
80 FR 13854
https://www.govinfo.gov/app/details/FR-2015-03-17/2015-06039
2015-06039
FR17MR15-54
4164-01-P
Docket No. FDA-2014-N-1206
https://www.govinfo.gov/app/details/FR-2015-03-17/2015-06039
https://www.govinfo.gov/content/pkg/FR-2015-03-17/html/2015-06039.htm
https://www.govinfo.gov/content/pkg/FR-2015-03-17/pdf/2015-06039.pdf
9 p.
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80 FR 13854
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-06039
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-12-23
Docket No. FDA-2014-N-1206
4164-01-P
2015-06039
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus in response to the 2014 Ebola virus outbreak in West Africa. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. (Roche). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
The Authorization is effective as of December 23, 2014.
Luciana Borio, Assistant Commissioner for Counterterrorism Policy, Office of Counterterrorism and Emerging Threats, and Acting Deputy Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4340, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).
Emergency Use Authorizations:
In Vitro Diagnostic Device for Detection of Ebola Zaire Virus
,
http://www.regulations.gov
Federal Register
Vol. 80, no. 51
Office of the Federal Register, National Archives and Records Administration
2015-03-17
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Table of Contents:
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