2 November 2009

[Federal Register: November 2, 2009 (Volume 74, Number 210)]
[Notices]               
[Page 56640-56641]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no09-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

 
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.

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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

[[Page 56641]]

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 (202) 205-2882 (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.
[FR Doc. E9-26294 Filed 10-30-09; 8:45 am]