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 2014_register executive 2014-10-07 article Notices D09002ee1c7f8d384 D09002ee1c7f8d3ee United States Department of Health and Human Services originator org United States Government Agency or Subagency The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On September 22, 2006, then Secretary of Homeland Security, Michael Chertoff, determined pursuant to section 319F-2 of the Public Health Service Act, 42 U.S.C. 247d-6b, that the Ebola virus presents a material threat against the United States population sufficient to affect national security. On the basis of this determination, on August 4, 2014 the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. 79 FR 47141 https://www.govinfo.gov/app/details/FR-2014-08-12/2014-19026 2014-19026 fr12au14-63 4150-37-P https://www.govinfo.gov/app/details/FR-2014-08-12/2014-19026 https://www.govinfo.gov/content/pkg/FR-2014-08-12/html/2014-19026.htm https://www.govinfo.gov/content/pkg/FR-2014-08-12/pdf/2014-19026.pdf 1 p. 47141 47141 79 FR 47141 Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus; Federal Register Vol. 79, Issue NOTICE 2014-19026 DEPARTMENT OF HEALTH AND HUMAN SERVICES 2014-08-04 4150-37-P 2014-19026 Notice.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On September 22, 2006, then Secretary of Homeland Security, Michael Chertoff, determined pursuant to section 319F-2 of the Public Health Service Act, 42 U.S.C. 247d-6b, that the Ebola virus presents a material threat against the United States population sufficient to affect national security. On the basis of this determination, on August 4, 2014 the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

The determination and declaration are effective August 4, 2014. Nicole Lurie, M.D., MSPH, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free number). Declarations Regarding Emergency Use: in vitro Diagnostics for Detection of Ebola Virus , Vol. 79, no. 155 Office of the Federal Register, National Archives and Records Administration 2014-08-12 continuing daily deposited born digital 421 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-08-12 P0b002ee189da2386 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr12au14 https://www.govinfo.gov/app/details/FR-2014-08-12 https://www.govinfo.gov/content/pkg/FR-2014-08-12/pdf/FR-2014-08-12.pdf https://www.govinfo.gov/content/pkg/FR-2014-08-12/xml/FR-2014-08-12.xml fdlp 46961 47372 DGPO 2014-10-07 2024-06-02 FR-2014-08-12 machine generated eng FR FR-2014-08-12 79 155