E9-26294. Determination and Declaration Regarding Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information

AGENCY:

Office of the Secretary (OS), HHS.

ACTION:

Notice.

SUMMARY:

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the then Acting Secretary of HHS determined that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009-H1N1 Influenza A, or 2009-H1N1 influenza) that affects or has significant potential to affect national security. On July 24 and October 1, 2009 the Secretary renewed that determination of a public health emergency. On the basis of this determination, on October 20, 2009 the Secretary declared an emergency justifying the authorization of emergency use of the antiviral product peramivir accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb-3(a). The Secretary also specified that this declaration is a declaration of emergency as defined in the Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Influenza Antiviral peramivir.

DATES:

The declaration of an emergency justifying the authorization of emergency use of the antiviral product peramivir is effective October 20, 2009.

FOR FURTHER INFORMATION CONTACT:

Nicole Lurie, M.D., 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:

I. Background

Under Section 564 of the FFDCA, the Commissioner, acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA) authorizing the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product, or an unapproved use of an approved drug, approved or cleared device, or licensed biological product. Before an EUA may be issued, the Secretary of HHS must declare an emergency justifying the authorization based on one of three determinations: A determination of a domestic emergency, or a significant potential for a domestic emergency, by the Secretary of Homeland Security; a determination of a military emergency, or a significant potential for a military emergency, by the Secretary of Defense; or a determination of a public health emergency by the Secretary of HHS. See 21 U.S.C. 360bbb-3(b)(1). In the case of a determination by the Secretary of HHS (as was made here), the Secretary must determine that a public health emergency exists under section 319 of the Public Health Service (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. Based on such a determination, the Secretary of HHS may then declare an emergency that justifies the EUA, at which point the Commissioner may issue an EUA if the criteria for issuance of an authorization under section 564 of the FFDCA are met.

The Centers for Disease Control and Prevention (CDC), HHS, requested that the Food and Drug Administration (FDA) issue an EUA for the antiviral product peramivir accompanied by emergency use information. The determination of a public health emergency by the Acting Secretary of HHS, renewal of that determination by the Secretary of HHS, and the declarations of an emergency by the Secretary of HHS based on that determination, as described below, enable the Commissioner to issue an EUA for certain antiviral products for emergency use under section 564(a) of the FFDCA, 21 U.S.C. 360bbb-3(a).

II. Determination of the Acting Secretary of Health and Human Services and Renewal of the Determination by the Secretary of Health and Human Services

On April 26, 2009, pursuant to section 564(b)(1)(C) of the FFDCA, 21 U.S.C. 360bbb-3(b)(1)(A), and section 319 of the PHS Act, 42 U.S.C. 247d, the Acting Secretary of HHS determined, as a consequence of confirmed cases of Swine Influenza A (now called “2009-H1N1 influenza”) in California, Texas, Kansas, and New York, and after consultation with public health officials as necessary, that a public health emergency exists nationwide involving 2009-H1N1 influenza that affects or has significant potential to affect national security.

On July 24 and October 1, 2009 pursuant to section 564(b)(1)(C) of the FFDCA, 21 U.S.C. 360bbb-3(b)(1)(A), and section 319 of the PHS Act, 42 U.S.C. 247d, because the 2009-H1N1 flu outbreak remains a worldwide public health threat and because the Department should use all available tools to ensure that we are prepared, and after consultation with public health officials as necessary, the Secretary renewed the April 26, 2009 determination by then Acting Secretary Charles E. Johnson that a public health emergency exists nationwide involving Swine Influenza A (now called “2009-H1N1 influenza”) that affects or has significant potential to affect national security.

III. Declaration of the Secretary of Health and Human Services

On October 20, 2009, on the basis of my renewal on July 24 and October 1, 2009, of the April 26, 2009 determination by Acting Secretary Charles E. Johnson that a public health emergency exists involving Swine Influenza A (now called “2009-H1N1 influenza”) that affects or has significant potential to affect national security, and pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b), I, Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services, hereby declare an emergency justifying the authorization of the emergency use of the antiviral peramivir, accompanied by emergency use information, subject to the terms of any authorization issued under 21 U.S.C. 360bbb-3(a). This declaration is a declaration of emergency, as defined in the Declaration under the Public Readiness and Emergency Preparedness Act for Influenza Antiviral peramivir, which was signed September 25, 2009, and any amendments thereto.

Notice of the authorizations issued by the FDA Commissioner under 21 U.S.C. 360bbb-3 is provided elsewhere in this Federal Register.

Dated: October 23, 2009.

Kathleen Sebelius,

Secretary.