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2017-06-30
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Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning; Availability
Notices
D09002ee1bdbbf59b
D09002ee1bdbbf654
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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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 injectable treatment for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized injectable treatment. The Authorization follows the April 11, 2017, determination by the Department of Health and Human Services (HHS) Secretary 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 nerve agents or certain insecticides (organophosphorus and/or carbamate). On the basis of such determination, the HHS Secretary declared on April 11, 2017, that circumstances exist justifying the authorization of emergency use of injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning, 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.
82 FR 29867
https://www.govinfo.gov/app/details/FR-2017-06-30/2017-13664
2017-13664
fr30jn17-101
4164-01-P
Docket No. FDA-2017-N-3224
https://www.govinfo.gov/app/details/FR-2017-06-30/2017-13664
https://www.govinfo.gov/content/pkg/FR-2017-06-30/html/2017-13664.htm
https://www.govinfo.gov/content/pkg/FR-2017-06-30/pdf/2017-13664.pdf
17 p.
29867
29883
82 FR 29867
Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning; Availability; Federal Register Vol. 82, Issue
NOTICE
2017-13664
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2017-04-11
Docket No. FDA-2017-N-3224
4164-01-P
2017-13664
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an injectable treatment for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized injectable treatment. The Authorization follows the April 11, 2017, determination by the Department of Health and Human Services (HHS) Secretary 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 nerve agents or certain insecticides (organophosphorus and/or carbamate). On the basis of such determination, the HHS Secretary declared on April 11, 2017, that circumstances exist justifying the authorization of emergency use of injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning, 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 April 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.
Emergency Use; Authorizations:
Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning
,
https://www.regulations.gov
Federal Register
Vol. 82, no. 125
Office of the Federal Register, National Archives and Records Administration
2017-06-30
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2017-06-30
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https://www.govinfo.gov/app/details/FR-2017-06-30
https://www.govinfo.gov/content/pkg/FR-2017-06-30/pdf/FR-2017-06-30.pdf
https://www.govinfo.gov/content/pkg/FR-2017-06-30/xml/FR-2017-06-30.xml
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