[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47197-47210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19622]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0543]


Authorization of Emergency Use of Oral Formulations of 
Doxycycline; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: The Authorization is effective as of July 21, 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, 
301-796-8510.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3), as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276), allows FDA to 
strengthen the public health protections against biological, chemical, 
nuclear, and radiological agents. Among other things, section 564 of 
the FD&C Act allows FDA to authorize the use of an unapproved medical 
product or an unapproved use of an approved medical product during a 
public health emergency that affects,

[[Page 47198]]

or has a significant potential to affect, national security, and that 
involves biological, chemical, radiological, or nuclear agent or 
agents, or a specified disease or condition that may be attributable to 
such agent or agents. With this EUA authority, FDA can help assure that 
medical countermeasures may be used in an emergency to diagnose, treat, 
or prevent serious or life-threatening diseases or conditions caused by 
such agents, when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary must declare an emergency justifying the 
authorization based on one of the following grounds: ``(A) 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 specified 
biological, chemical, radiological, or nuclear agent or agents; (B) a 
determination by the Secretary of Defense that there is a military 
emergency, or a significant potential for a military emergency, 
involving a heightened risk to United States military forces of attack 
with a specified biological, chemical, radiological, or nuclear agent 
or agents; or (C) a determination by the Secretary of a public health 
emergency under section 319 of the Public Health Service Act (PHS Act) 
that affects, or has a significant potential to affect, national 
security, and that involves a specified biological, chemical, 
radiological, or nuclear agent or agents, or a specified disease or 
condition that may be attributable to such agent or agents.''
    Once the Secretary has declared an emergency justifying an 
authorization under section 564 of the FD&C Act, FDA may authorize the 
emergency use of a drug, device, or biological product if the Agency 
concludes that the statutory criteria are satisfied. Under section 
564(h)(1) of the FD&C Act, FDA is required to publish, in the Federal 
Register, a notice of each authorization, and each termination or 
revocation of an authorization, and an explanation of the reasons for 
the action. Section 564 of the FD&C Act permits FDA to authorize the 
introduction into interstate commerce of a drug, device, or biological 
product intended for use in a declared emergency. Products appropriate 
for emergency use may include products and uses that are not approved, 
cleared, or licensed under sections 505, 510(k), and 515 of the FD&C 
Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the PHS Act (42 
U.S.C. 262). FDA may issue an EUA only if, after consultation with the 
National Institutes of Health and CDC (to the extent feasible and 
appropriate given the circumstances of the emergency), FDA \1\ 
concludes: (1) That an agent specified in a declaration of emergency 
can cause a serious or life-threatening disease or condition; (2) that, 
based on the totality of scientific evidence available to FDA, 
including data from adequate and well-controlled clinical trials, if 
available, it is reasonable to believe that: (A) the product may be 
effective in diagnosing, treating, or preventing--(1) Such disease or 
condition; or (2) a serious or life-threatening disease or condition 
caused by a product authorized under section 564, approved or cleared 
under the FD&C Act, or licensed under section 351 of the PHS Act, for 
diagnosing, treating, or preventing such a disease or condition caused 
by such an agent; and (B) the known and potential benefits of the 
product, when used to diagnose, prevent, or treat such disease or 
condition, outweigh the known and potential risks of the product; (3) 
that there is no adequate, approved, and available alternative to the 
product for diagnosing, preventing, or treating such disease or 
condition; and (4) that such other criteria as the Secretary may by 
regulation prescribe are satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary has delegated her authority to issue an EUA 
under section 564 of the FD&C Act to the Commissioner of Food and 
Drugs.
---------------------------------------------------------------------------

    No other criteria of issuance have been prescribed by regulation 
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, FDA does not require regulations or guidance to implement 
the EUA authority. However, in the Federal Register of July 26, 2007 
(72 FR 41083), FDA announced the availability of a guidance entitled 
``Emergency Use Authorization of Medical Products.'' The guidance 
provides more information for stakeholders and the public about the EUA 
authority and the Agency's process for the consideration of EUA 
requests.

II. EUA Request for Oral Formulations of Doxycycline Products

    In 2004, the Secretary of DHS issued a material threat 
determination indicating that B. anthracis, the biological agent that 
causes anthrax disease, presents a material threat against the 
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, the 
Secretary of DHS 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, 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 that declaration. On 
July 20, 2011, the Secretary of HHS renewed and amended that 
declaration so that it applies to all doxycycline products covered by 
this authorization. Notice of the determination and the declaration of 
the Secretary were published in the Federal Register on July 27, 2011 
(76 FR 44926). On May 5, 2011, CDC requested and, on July 21, 2011, FDA 
issued an EUA for oral formulations of doxycycline products for the 
post-exposure prophylaxis of inhalational anthrax during a public 
health emergency involving aerosolized B. anthracis, subject to the 
terms and conditions of this authorization.

III. 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.

IV. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization under section 564(c) of the FD&C Act are met, FDA has 
authorized the emergency use of oral formulations of doxycycline 
products for the post-exposure prophylaxis of inhalational anthrax 
during a public health emergency involving aerosolized B. anthracis 
subject to the terms and conditions of the authorization.
    The Authorization for doxycycline products follows and provides an 
explanation of the reasons for its issuance, as required by section 
564(h)(1) of the FD&C Act:
BILLING CODE 4160-01-P

[[Page 47199]]

[GRAPHIC] [TIFF OMITTED] TN04AU11.021


[[Page 47200]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.022


[[Page 47201]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.023


[[Page 47202]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.024


[[Page 47203]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.025


[[Page 47204]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.026


[[Page 47205]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.027


[[Page 47206]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.028


[[Page 47207]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.029


[[Page 47208]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.030


[[Page 47209]]


[GRAPHIC] [TIFF OMITTED] TN04AU11.031

[GRAPHIC] [TIFF OMITTED] TN04AU11.032



[[Page 47210]]


    Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19622 Filed 8-3-11; 8:45 am]
BILLING CODE 4160-01-C