[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72935-72950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30450]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0264]


Amended Authorization of Emergency Use of Doxycycline Hyclate 
Tablet Emergency Kits for Eligible United States Postal Service 
Participants and Their Household Members; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the Emergency Use Authorization (EUA) (the Authorization) 
for doxycycline hyclate tablet emergency kits for eligible United 
States Postal Service (USPS) participants in the Cities Readiness 
Initiative (CRI) and their household members issued on October 3, 2008, 
as amended on February 25, 2009, and on August 23, 2010, under the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by 
the Biomedical Advanced Research and Development Authority (BARDA), 
Office of the Assistant Secretary for Preparedness and Response (ASPR), 
Department of Health and Human Services (HHS). Following issuance of 
FDA's August 23, 2010, amended Authorization letter, on April 8, 2011, 
BARDA submitted a request on behalf of ASPR to further amend the 
Authorization to reflect certain programmatic changes, including by 
replacing references to the CRI with the National Postal Model (NPM). 
In response to BARDA's request, FDA amended the Authorization letter 
and reissued the Authorization in its entirety on October 14, 2011. The 
Authorization, as amended and reissued, includes explanations for its 
reissuance and is reprinted in this document.

DATES: The amended Authorization is effective as of October 14, 2011.

ADDRESSES: Submit written requests for single copies of the EUA to the 
Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4121, Silver 
Spring, MD 20993. Send one self-addressed adhesive label to assist that 
office in processing your request or include a fax number to which the 
Authorization may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Luciana Borio, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 4280, Silver Spring, MD 20993-
0002, (301) 796-4637.

SUPPLEMENTARY INFORMATION: 

I. Amendment to the October 3, 2008, Authorization for Doxycyline 
Hyclate Tablet Emergency Kits, as Amended

    In 2004, the Secretary of the Department of Homeland Security (DHS) 
issued a material threat determination indicating that Bacillus 
anthracis (B. anthracis), the biological agent that causes anthrax 
disease, presents a material threat against the

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population of the United States sufficient to affect national security. 
On September 23, 2008, under section 564(b)(1)(A) of the FD&C Act (21 
U.S.C. 360bbb-3(b)(1)(A)), as amended by the Project BioShield Act of 
2004 (Pub. L. 108-276), the Secretary of DHS determined that there is a 
significant potential for a domestic emergency involving a heightened 
risk of attack with a specific biological, chemical, radiological, or 
nuclear agent or agents--in this case, B. anthracis. On October 1, 
2008, under section 564(b) of the FD&C Act, and on the basis of such 
determination, the Secretary of HHS then declared an emergency 
justifying the authorization of 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, 
and on October 1, 2009, and on October 1, 2010, renewed the 
declaration. On July 20, 2011, the Secretary of HHS renewed and amended 
the declaration to apply to all oral formulations of doxycycline, 
including doxycycline hyclate tablets covered by the Authorization, 
accompanied by emergency use information subject to the terms of any 
authorization issued under section 564(a) of the FD&C Act. Notice of 
the declaration of the Secretary was published in the Federal Register 
of July 27, 2011 (76 FR 44926).
    On October 1, 2008, BARDA requested and on October 3, 2008, FDA 
issued an EUA for doxycycline hyclate tablet emergency kits for 
eligible USPS participants in the CRI and their household members, 
subject to the terms and conditions of the Authorization. As required 
under section 564(h)(1) of the FD&C Act, in the Federal Register of 
October 21, 2008 (73 FR 62507), FDA published the Authorization for 
doxycycline tablet emergency kits for eligible USPS participants in the 
CRI and their household members, including an explanation of the 
reasons for its issuance. On February 19, 2009, BARDA submitted a 
request on behalf of ASPR to amend the Authorization to make certain 
changes to the written information authorized to accompany the 
doxycycline hyclate tablet emergency kits and to clarify the roles and 
responsibilities provided for in the Authorization. On February 25, 
2009, in response to BARDA's request, FDA amended the Authorization 
letter and reissued the Authorization letter in its entirety. In the 
Federal Register of June 26, 2009 (74 FR 30577), FDA published the 
amended Authorization, including an explanation of the reasons for the 
amendment. On August 4, 2010, BARDA requested that the EUA be further 
amended to permit the use of a certain manufacturer and a certain 
repackager under the EUA. On August 23, 2010, in response to BARDA's 
request, FDA amended the Authorization letter and reissued the 
Authorization letter in its entirety. On April 8, 2011, BARDA requested 
that the EUA be further amended to reflect programmatic and operational 
changes, including by replacing references to the CRI with the NPM, 
clarifying roles and responsibilities, and revising or removing certain 
written materials provided for in the Authorization. On October 14, 
2011, in response to BARDA's request, FDA amended the Authorization 
letter and reissued the Authorization letter in its entirety.

II. Electronic Access

    An electronic version of this document and the full text of the 
Authorization are available on the Internet at http://www.regulations.gov.

III. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization under section 564(c) of the FD&C Act were met, on October 
3, 2008, FDA authorized the emergency use of doxycycline hyclate tablet 
emergency kits for eligible USPS participants in the CRI and their 
household members subject to the terms and conditions of the 
Authorization. The letter of Authorization in its entirety (not 
including the amended authorized versions of the fact sheets and other 
written materials), as amended on February 25, 2009, on August 23, 
2010, and on October 14, 2011, follows and provides an explanation of 
the reasons for its amendment.

    Dated: November 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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[FR Doc. 2011-30450 Filed 11-25-11; 8:45 am]
BILLING CODE 4164-01-C