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2011-08-04
article
Authorization of Emergency Use of Oral Formulations of Doxycycline; Availability
Notices
D09002ee1bdcfce0a
D09002ee1bdcfcea8
United States
Department of Health and Human Services
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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 oral formulations of doxycycline for the post-exposure prophylaxis of inhalational anthrax during a public health emergency involving aerosolized Bacillus anthracis (B. anthracis). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized doxycycline products. The Authorization follows the determination by the Secretary of the Department of Homeland Security (DHS) that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, B. anthracis. On the basis of such determination, the Secretary of the Department of Health and Human Services (HHS) declared an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets, accompanied by emergency use information, and later renewed that declaration. The Secretary of HHS then renewed and amended that declaration so that it applies to all doxycycline products covered by this authorization. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
76 FR 47197
https://www.govinfo.gov/app/details/FR-2011-08-04/2011-19622
2011-19622
fr04au11-64
4160-01-P
Docket No. FDA-2011-N-0543
https://www.govinfo.gov/app/details/FR-2011-08-04/2011-19622
https://www.govinfo.gov/content/pkg/FR-2011-08-04/html/2011-19622.htm
https://www.govinfo.gov/content/pkg/FR-2011-08-04/pdf/2011-19622.pdf
14 p.
47197
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76 FR 47197
Authorization of Emergency Use of Oral Formulations of Doxycycline; Availability; Federal Register Vol. 76, Issue
NOTICE
2011-19622
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2011-07-21
Docket No. FDA-2011-N-0543
4160-01-P
2011-19622
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for oral formulations of doxycycline for the post-exposure prophylaxis of inhalational anthrax during a public health emergency involving aerosolized Bacillus anthracis (B. anthracis). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized doxycycline products. The Authorization follows the determination by the Secretary of the Department of Homeland Security (DHS) that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, B. anthracis. On the basis of such determination, the Secretary of the Department of Health and Human Services (HHS) declared an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets, accompanied by emergency use information, and later renewed that declaration. The Secretary of HHS then renewed and amended that declaration so that it applies to all doxycycline products covered by this authorization. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
The Authorization is effective as of July 21, 2011.
Luciana Borio, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4280, Silver Spring, MD 20993, 301-796-8510.
Authorization of Emergency Use of Oral Formulations of Doxycycline; Availability
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http://www.regulations.gov
Federal Register
Vol. 76, no. 150
Office of the Federal Register, National Archives and Records Administration
2011-08-04
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2011-08-04
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https://www.govinfo.gov/app/details/FR-2011-08-04
https://www.govinfo.gov/content/pkg/FR-2011-08-04/pdf/FR-2011-08-04.pdf
https://www.govinfo.gov/content/pkg/FR-2011-08-04/xml/FR-2011-08-04.xml
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2011-08-04
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FR-2011-08-04
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