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

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.

Table of Contents

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 thepopulation 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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