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2018-10-25
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Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability
Notices
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D09002ee1bdbaa5a8
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 two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Thermo Fisher Scientific and The Center for Infection and Immunity, Columbia University. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
82 FR 49612
https://www.govinfo.gov/app/details/FR-2017-10-26/2017-23224
2017-23224
fr26oc17-53
4164-01-P
Docket No. FDA-2016-N-1486
https://www.govinfo.gov/app/details/FR-2017-10-26/2017-23224
https://www.govinfo.gov/content/pkg/FR-2017-10-26/html/2017-23224.htm
https://www.govinfo.gov/content/pkg/FR-2017-10-26/pdf/2017-23224.pdf
21 p.
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82 FR 49612
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability; Federal Register Vol. 82, Issue
NOTICE
2017-23224
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2017-08-11
Docket No. FDA-2016-N-1486
4164-01-P
2017-23224
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Thermo Fisher Scientific and The Center for Infection and Immunity, Columbia University. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
The Authorization for Thermo Fisher Scientific is applicable as of August 2, 2017; the Authorization for The Center for Infection and Immunity, Columbia University is effective as of August 11, 2017.
Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993- 0002, 301-796-8510 (this is not a toll free number).
Emergency Uses; Authorizations:
In Vitro Diagnostic Devices for Detection of Zika Virus
,
https://www.regulations.gov
Federal Register
Vol. 82, no. 206
Office of the Federal Register, National Archives and Records Administration
2017-10-26
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2017-10-26
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https://www.govinfo.gov/app/details/FR-2017-10-26
https://www.govinfo.gov/content/pkg/FR-2017-10-26/pdf/FR-2017-10-26.pdf
https://www.govinfo.gov/content/pkg/FR-2017-10-26/xml/FR-2017-10-26.xml
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