2010-24840. Renewal of Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information

AGENCY:

Office of the Secretary (OS), HHS.

ACTION:

Notice.

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. On the basis of this determination, the Secretary of Health and Human Services is renewing the October 1, 2008 declaration by former Secretary Michael O. Leavitt of 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). This notice is being issued in accordance with section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).

DATES:

This Notice and referenced HHS declaration are effective as of October 1, 2010.

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 [phone] (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

On September 23, 2008, former Secretary of Homeland Security, Michael Chertoff, 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, 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. 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, former Secretary of Health and Human Services, Michael O. Leavitt, 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).^[1] Pursuant to section 564(b)(2)(B) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b), and on the basis of Secretary Chertoff's September 23, 2008 determination, I hereby renew former Secretary Leavitt's October 1, 2008 declaration of an emergency, which I previously renewed on October 1, 2009, 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). I am issuing this notice in accordance with section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).

Dated: September 24, 2010.

Kathleen Sebelius,

Secretary.

Footnotes

1.  Pursuant to section 564(b)(4) of the FFDCA, notice of the determination by the Secretary, DHS, and the declaration by the Secretary, HHS, was provided at 73 FR 58242 (October 6, 2008).