Notice: Determination and Declaration Regarding Emergency Use of 
Doxycycline Hyclate Tablets Accompanied by Emergency Use Information

Federal Register: October 6, 2008 (Volume 73, Number 194)          
                  Page 58242-58243

AGENCY: Office of the Secretary (OS), HHS.

ACTION: Notice.

SUMMARY: The Secretary of the Department of Health and Human Services 
(HHS) is issuing this notice pursuant to section 564(b)(4) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4), 
to justify the emergency use of doxycycline hyclate tablets accompanied 
by emergency use information, contained in emergency kits for eligible 
United States Postal Service (USPS) Cities Readiness Initiative (CRI) 
participants and their household members in advance of a potential 
attack involving Bacillus anthracis. Bacillus anthracis is a biological 
agent known to cause anthrax. The Secretary, HHS, provides notice of 
the determination of the Secretary of Homeland Security 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, 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. The Secretary also provides notice that, 
on the basis of such determination, he has declared an emergency 
justifying the authorization of emergency use of doxycycline hyclate 
tablets accompanied by emergency use information subject to the terms 
of any authorization issued by the Food and Drug Commissioner under 21 
U.S.C. 360bbb-3(a).

DATES: This Notice and referenced HHS declaration are effective as of 
October 1, 2008.

FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, M.D., 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

    The CRI, begun in 2004, is a federally supported effort to prepare 
72 major U.S. metropolitan areas to effectively respond to a large-
scale bioterrorist event by dispensing antibiotics to their entire 
identified population within 48 hours of the decision to do so. Over 
the past several years, HHS and the USPS have developed and tested in 
three U.S. cities--Seattle, Philadelphia and Boston--the ability of 
letter carriers to quickly deliver door-to-door a few days' worth of 
antibiotics to residential addresses. This quick-strike capability is 
intended to buy time for State and local public health authorities to 
set up points of dispensing for further provision of antibiotics across 
the community, as needed.
    Under Section 564 of the FFDCA, the Secretary of Homeland Security 
may determine that there is a domestic emergency, or a significant 
potential for a domestic emergency, involving a heightened risk of 
attack with a specified biological chemical, radiological or nuclear 
agent or agents.

[[Page 58243]]

Based on such a determination, the Secretary of Health and Human 
Services may declare an emergency that justifies the authorization of a 
product that is not otherwise approved, licensed or cleared for 
commercial use (``unapproved product'') or is not approved, licensed, 
or cleared for a particular use (``unapproved use of an approved 
product.''). Following that declaration, the Commissioner of the Food 
and Drug Administration (FDA) may issue an Emergency Use Authorization 
(EUA).
    The Biomedical Advanced Research and Development Authority (BARDA) 
of the HHS Office of the Assistant Secretary for Preparedness and 
Response (ASPR) has requested that FDA issue an EUA for doxycycline 
hyclate tablets accompanied by emergency use information for use by 
eligible USPS participants in the CRI and their household members. 
Doxycyline hyclate tablets are approved by the FDA for the post-
exposure prophylaxis of anthrax. However, the doxycycline hyclate 
tablets for which BARDA seeks an EUA would be accompanied by emergency 
use information that is not included in any of the approved 
applications for doxyclycline hyclate tablets. For this reason, an EUA 
is necessary. The September 23, 2008 determination by the Secretary of 
Homeland Security 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, and the October 1, 2008 declaration by the 
Secretary of Health and Human Services based on that determination that 
there is an emergency justifying the authorization of emergency use of 
doxycycline hyclate tablets accompanied by emergency use information, 
enables the FDA Commissioner to issue an EUA for doxycyline hyclate 
tablet emergency kits under section 564(a) of the FFDCA, 21 U.S.C. 
360bbb-3(a).
    With issuance of the EUA, eligible letter carriers participating in 
the CRI may receive the doxycycline hyclate tablet emergency kits, if 
not medically contraindicated, for future use by them and other members 
of their households during an anthrax emergency, subject to the terms 
of the authorization. The antibiotics and accompanying information may 
help protect these letter carriers and household members against 
contracting anthrax if, following an outdoor anthrax attack, the USPS 
is called upon to deliver the same or similar antibiotics to homes 
across their community where people may have been exposed to Bacillus 
anthracis. In an anthrax attack, time is of the essence in preventing 
illness and death by getting antibiotics to people who may have been 
exposed. By providing advance protection to letter carriers who 
willingly put themselves at risk by delivering antibiotics in an 
affected community, the unique capabilities of the USPS may be used to 
get antibiotics to those who need them quickly.
    The USPS initiative and EUA are one part of the Federal 
Government's strategy to encourage preparedness at all levels of 
government to enable the nation to respond effectively in the event of 
an anthrax emergency.

II. Determination of the Secretary of Homeland Security

    On September 23, 2008, pursuant to section 564(b)(1)(A) of the 
FFDCA, 21 U.S.C. 360bbb-3(b)(1)(A), the Secretary of Homeland Security 
determined 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. The Secretary of Homeland Security made this 
determination in a September 23, 2008 memorandum addressed to the 
Secretary of Health and Human Services. In that memorandum, the 
Secretary of Homeland Security stated that there is not currently a 
domestic emergency involving anthrax, there is not currently a 
heightened risk of an anthrax attack, and his Department has no 
credible information indicating an imminent threat of an attack 
involving Bacillus anthracis.
    The Secretary of Homeland Security determined that there is a 
significant potential for a domestic emergency, involving a heightened 
risk of attack with Bacillus anthracis, on two bases: (1) The 
Department of Homeland Security has already found that an anthrax 
attack poses a material threat to the United States population 
sufficient to affect national security, which allows the Secretary to 
conclude that there is a non-negligible possibility that a heightened 
risk of attack will arise. The finding that an anthrax attack poses a 
material threat to the United States population sufficient to affect 
national security was made on January 20, 2004 regarding anthrax, and 
on September 22, 2006 regarding multi-drug resistant Bacillus 
anthracis, pursuant to section 319F-2(c)(2) of the Public Health 
Service (PHS) Act, 42 U.S.C. 247d-6b(c)(2). (2) Were the government to 
determine in the future that there is a heightened risk of an anthrax 
attack--if, for example, there were credible information about an 
imminent threat of such an attack--that would almost certainly result 
in a domestic emergency. That is so, among other important reasons, 
because those exposed to Bacillus anthracis need to take appropriate 
antimicrobials rapidly after exposure to avoid contracting anthrax and 
because of the significant challenges to rapidly delivering such 
antimicrobials to those at risk in an anthrax emergency.
    Given his determination that there is a significant potential for a 
domestic emergency, the Secretary of Homeland Security also urged the 
Secretary of Health and Human Services to employ all relevant emergency 
powers under section 564 of the FFDCA to ensure distribution of pre-
need countermeasures that may be effective in preventing the 
contracting of anthrax by people in the delivery chain, such as USPS 
workers; first responders, including law enforcement; to essential 
government and non-government workers; and to the general public.

III. Declaration of the Secretary of Health and Human Services

    On September 23, 2008, the Secretary of the Department of Homeland 
Security determined 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) of 
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b), and on 
the basis of such determination, on October 1, 2008, I 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 21 U.S.C. 
360bbb-3(a).

    Dated: October 1, 2008.
Michael O. Leavitt,
Secretary.
 [FR Doc. E8-23544 Filed 10-1-08; 4:15 pm]

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