[Federal Register Volume 78, Number 129 (Friday, July 5, 2013)]
[Notices]
[Pages 40479-40480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16177]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Declaration That Circumstances Exist Justifying Authorization of 
Emergency Use of All Oral Formulations of Doxycycline Accompanied by 
Emergency Use Information

AGENCY: Office of the Secretary (OS), Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: The Secretary of Homeland Security determined on September 23, 
2008, 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, 
Bacillus anthracis--pursuant to section 564(b)(1)(A) of the Federal 
Food, Drug, and Cosmetic (FD&C) Act.\1\ On the basis of that 
determination, and pursuant to section 564(b) of the FD&C Act, the 
Secretary of Health and Human Services (HHS) is declaring that 
circumstances exist justifying the authorization of emergency use of 
all oral formulations of doxycycline accompanied by emergency use 
information subject to the terms of any authorization issued by the 
Commissioner of Food and Drugs under section 564(a) of the FD&C Act. 
This notice is being issued in accordance with section 564(b)(4) of the 
FD&C Act.
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    \1\ Section 564 of the FD&C Act is codified at 21 U.S.C. 360bbb-
3.

DATES: This Notice and referenced HHS declaration are effective as of 
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June 27, 2013.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, 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).

SUPPLEMENTARY INFORMATION: 

I. Background

    On September 23, 2008, former Secretary of Homeland Security,

[[Page 40480]]

Michael Chertoff, determined, pursuant to section 564(b)(1)(A) of the 
FD&C Act, 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, Bacillus anthracis--although there is no current domestic 
emergency involving anthrax, no current heightened risk of an anthrax 
attack, and no credible information indicating an imminent threat of an 
attack involving Bacillus anthracis. On October 1, 2008, on the basis 
of that determination, and pursuant to section 564(b) of the FD&C Act, 
former HHS Secretary, Michael O. Leavitt, declared an emergency 
justifying the emergency use of doxycycline hyclate tablets accompanied 
by emergency use information subject to the terms of any authorization 
issued under section 564(a) of the FD&C Act.\2\ On October 1, 2009 and 
October 1, 2010, I renewed the former Secretary's declaration,\3\ and 
on July 20, 2011, I renewed and amended the declaration to declare that 
the emergency justifies emergency use of all oral formulations of 
doxycycline accompanied by emergency use information subject to the 
terms of any authorization issued under section 564(a) of the FD&C 
Act.\4\ On June 28, 2012, I renewed my July 20, 2011 declaration.\5\
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    \2\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the 
determination by the Secretary of Homeland Security and the 
declaration by the HHS Secretary was provided at 73 FR 58242 
(October 6, 2008).
    \3\ Pursuant to section 564(b)(4) of the FD&C Act, notices of 
the renewals of the declaration of the HHS Secretary were provided 
at 74 FR 51,279 (Oct. 6, 2009) and 75 FR 61,489 (Oct. 5, 2010).
    \4\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the 
renewal and amendment of the declaration of the HHS Secretary was 
provided at 76 FR 44,926 (July 27, 2011).
    \5\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the 
renewal of the declaration of the HHS Secretary was provided at 77 
FR 39,708 (July 5, 2012).
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II. Declaration of the Secretary of Health and Human Services

    On the basis of the September 23, 2008 determination by the 
Secretary of Homeland Security and pursuant to section 564(b) of the 
FD&C Act, I hereby declare that circumstances exist justifying the 
authorization of emergency use of all oral formulations of doxycycline 
accompanied by emergency use information subject to the terms of any 
authorization issued under section 564(a) of the FD&C Act.\6\ I am 
issuing this notice in accordance with section 564(b)(4) of the FD&C 
Act.
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    \6\ Section 564(b)(1) of the FD&C Act was amended by section 302 
of the Pandemic and All-Hazards Preparedness Reauthorization Act, 
Public Law 113-5, to provide that the HHS Secretary may ``make a 
declaration that the circumstances exist justifying the 
authorization'' for a product under section 564 of the FD&C Act on 
the basis of one of four determinations specified under subsection 
564(b)(1) of the FD&C Act, including a determination by the 
Secretary of Homeland Security that there is a domestic emergency, 
or a significant potential for a domestic emergency, involving a 
heightened risk of attack with a chemical, biological, radiological, 
or nuclear agent or agents.

    Dated: June 27, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-16177 Filed 7-3-13; 8:45 am]
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