United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-04-22 article Notices D09002ee1c7f6477a D09002ee1c7f64810 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org 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 Ebola virus outbreak in West Africa. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by OraSure Technologies, Inc. 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 diagnostic devices 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. 81 FR 23709 https://www.govinfo.gov/app/details/FR-2016-04-22/2016-09369 2016-09369 fr22ap16-76 4164-01-P Docket No. FDA-2014-N-1206 https://www.govinfo.gov/app/details/FR-2016-04-22/2016-09369 https://www.govinfo.gov/content/pkg/FR-2016-04-22/html/2016-09369.htm https://www.govinfo.gov/content/pkg/FR-2016-04-22/pdf/2016-09369.pdf 12 p. 23709 23720 81 FR 23709 Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability; Federal Register Vol. 81, Issue NOTICE 2016-09369 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-03-04 Docket No. FDA-2014-N-1206 4164-01-P 2016-09369 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 Ebola virus outbreak in West Africa. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by OraSure Technologies, Inc. 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 diagnostic devices 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 March 4, 2016. 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). Authorizations of Emergency Use: In Vitro Diagnostic Device for Detection of Ebola Zaire Virus , http://www.regulations.gov Vol. 81, no. 78 Office of the Federal Register, National Archives and Records Administration 2016-04-22 continuing daily deposited born digital 455 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-04-22 P0b002ee18f42d766 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr22ap16 https://www.govinfo.gov/app/details/FR-2016-04-22 https://www.govinfo.gov/content/pkg/FR-2016-04-22/pdf/FR-2016-04-22.pdf https://www.govinfo.gov/content/pkg/FR-2016-04-22/xml/FR-2016-04-22.xml fdlp 23563 24008 DGPO 2016-04-22 2024-06-02 FR-2016-04-22 machine generated eng FR FR-2016-04-22 81 78