[Federal Register Volume 75, Number 63 (Friday, April 2, 2010)]
[Notices]
[Pages 16810-16812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7529]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Determination and Declarations Regarding Emergency Use of Certain 
In vitro Diagnostic, Antiviral, and Personal Respiratory Products 
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 national security. On the basis of this 
determination, on April 26 and April 27, 2009, the then Acting 
Secretary declared emergencies justifying the authorization of 
emergency use of certain in vitro diagnostic, antiviral, and personal 
respiratory protection products 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 then Acting Secretary also specified that these declarations 
are declarations of emergency as defined by former Secretary Michael O. 
Leavitt in the October 10, 2008 Declaration under the Public Readiness 
and Emergency Preparedness (PREP) Act for Influenza Antivirals 
Oseltamivir Phosphate and Zanamavir, as amended, and the December 17, 
2008 Declaration under the PREP Act for Pandemic Influenza Diagnostics, 
Personal Respiratory Protection Devices, and Respiratory Support 
Devices. The Secretary renewed the then Acting Secretary's 
determination that a public health emergency exists nationwide 
involving Swine Influenza A (now known as 2009 H1N1 Influenza) on July 
24, October 1, and December 28, 2009, and March 26, 2010. Also on March 
26, 2010, the Secretary renewed the then Acting Secretary's 
declarations of emergency justifying the authorization of emergency use 
of certain in vitro diagnostic, antiviral, and personal respiratory 
protection products 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).

DATES: The declaration of an emergency justifying the authorization of 
emergency use of certain in vitro diagnostic products is renewed 
effective March 26, 2010. The declaration of an emergency justifying 
the authorization of certain antiviral products is renewed effective 
March 26, 2010. The declaration of an emergency justifying the 
authorization of emergency use of certain respiratory protection 
products is renewed effective March 26, 2010.

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

[[Page 16811]]

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 EUAs for 
certain in vitro diagnostic, antiviral, and personal respiratory 
protection products accompanied by emergency use information. The 
determination of a public health emergency by the then Acting Secretary 
and declarations of an emergency by the then Acting Secretary based on 
that determination, published at 74 FR 38628 (August 4, 2009), enabled 
the then Acting Commissioner to issue EUAs for certain in vitro 
diagnostic, antiviral, and personal respiratory protection products, 
published at 74 FR 38636 (August 4, 2009), 71 FR 38641 (August 4, 2009) 
and 71 FR 38645 (August 4, 2009). The CDC has requested that the FDA 
continue these EUAs to support continued surveillance of 2009 H1N1 
influenza through use of certain in vitro diagnostic products. 
Continuation of the EUAs is also important to support continued 
availability and disposition of certain antiviral products to treat 
individuals who are ill following exposure to 2009 H1N1 influenza and 
to support continued availability and disposition of certain personal 
respiratory products to help reduce wearer exposure to airborne viruses 
during the 2009 H1N1 influenza emergency. The renewed determination of 
a public health emergency by the Secretary of HHS and the renewed 
declarations of an emergency by the Secretary of HHS based on that 
determination justify the authorization of the emergency use of the 
above products.
    In this public health emergency involving 2009 H1N1 influenza, time 
continues to be of the essence in detecting, preventing, and treating 
illness and death by getting in vitro diagnostic, antiviral, and 
personal respiratory protection products, accompanied by emergency use 
information, to the general public, laboratories, and public health and 
health care professionals. By continuing to distribute certain in vitro 
diagnostic products accompanied by emergency use information, public 
health and health care professionals can ensure that any continued 
spread of the 2009 H1N1 influenza is quickly and accurately detected. 
By dispensing certain personal respiratory products accompanied by 
emergency use information, the appropriate State and/or public health 
authority(ies) can ensure that the products are provided quickly, as 
appropriate, to help reduce wearer exposure to airborne germs. By 
dispensing certain antiviral products accompanied by emergency use 
information, public health and medical professionals and the 
authorities having jurisdiction to respond to the emergency in each 
locality can ensure that the products are provided quickly, as 
appropriate, to treat those who may have been exposed or are ill.
    This is one part of the Federal Government's strategy to encourage 
continued preparedness at all levels of government to enable the nation 
to respond effectively in response to this public health emergency.

II. Determination of the Secretary of Health and Human Services

    On March 26, 2010, 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. The Secretary renewed the Acting 
Secretary's determination, after consultation with public health 
officials as necessary and pursuant to authority under section 319 of 
the Public Health Service Act 42 U.S.C. 247d, because the 2009 H1N1 
Influenza outbreak remains a worldwide public health threat. The 
Secretary previously renewed the Acting Secretary's determination on 
July 24, 2009, October 1, 2009, and December 28, 2009.

III. Declarations of the Secretary of Health and Human Services

    On March 26, 2010, the Secretary renewed the April 26, 2009 
declaration by then Acting Secretary Charles E. Johnson of an emergency 
justifying the authorization of the emergency use of certain in vitro 
diagnostics for detection of Swine Influenza A (now called 2009 H1N1 
Influenza) accompanied by emergency use information subject to the 
terms of any authorization issued under 21 U.S.C. 360bbb-3(a). This 
renewal was made on the basis of the April 26, 2009 determination by 
then Acting Secretary Charles E. Johnson, pursuant to section 319 of 
the Public Health Service Act, 42 U.S.C. 247d, 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, a determination which was renewed on July 24, 
2009, October 1, 2009, December 28, 2009 and March 26, 2010 because 
2009 H1N1 flu outbreak remains a public health threat and the 
Department should use all available tools to ensure that the nation is 
prepared. The renewal of this April 26, 2009 declaration was made 
pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act, 
21 U.S.C. 360bbb-3(b). In renewing the declaration, the Secretary 
further specified that the declaration is a declaration of emergency, 
as defined in the December 17, 2008 Declaration under the Public 
Readiness and Emergency Preparedness Act for Influenza Diagnostics, 
Personal Respiratory Protection Devices, and Respiratory Support 
Devices, 73 FR 78362 (December 22, 2008).
    Also on March 26, 2010, the Secretary renewed the April 26, 2010 
declaration by then Acting Secretary Charles E. Johnson of an emergency 
justifying the authorization of the emergency use of certain products 
from the neuraminidase class of Antivirals Oseltamivir Phosphate and 
Zanamivir accompanied by emergency use information subject to the terms 
of any authorization issued under 21 U.S.C. 360bbb-3(a). This renewal 
was made on the basis of the April 26, 2009 determination by then 
Acting Secretary Charles E. Johnson, pursuant to section 319 of the 
Public Health Service Act, 42 U.S.C. 247d, 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, a determination which was renewed on July 24, 
2009, October 1, 2009, December 28, 2009, and March 26, 2010 because 
2009 H1N1 flu outbreak remains a public health threat and the 
Department should use all available tools to ensure the nation is 
prepared. The renewal of this April 26, 2009 declaration was made 
pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act, 
21 U.S.C. 360bbb-3(b). In renewing the declaration, the Secretary 
further specified that the declaration is a declaration of emergency, 
as defined in the October 10, 2008 Declaration under the Public 
Readiness and Emergency Preparedness Act for Influenza Antivirals 
Oseltamivir Phosphate and Zanamivir, 73 FR 61861 (October 17, 2008), as 
amended at 74 FR 2913 (April 26, 2009).
    Also on March 26, 2010, the Secretary renewed the April 27, 2009 
declaration by then Acting Secretary Charles E. Johnson of an emergency 
justifying the authorization of the emergency use of

[[Page 16812]]

certain personal respiratory protection devices, accompanied by 
emergency use information subject to the terms of any authorization 
issued under 21 U.S.C 360bbb-3(a). This renewal was made on the basis 
of the April 26, 2009 determination by then Acting Secretary Charles E. 
Johnson, pursuant to section 319 of the Public Health Service Act, 42 
U.S.C. 247d, 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, a determination 
which was renewed on July 24, 2009, October 1, 2009, December 28, 2009 
and March 26, 2010 because 2009 H1N1 flu outbreak remains a public 
health threat and the Department should use all available tools to 
ensure that the nation is prepared. The renewal of this April 27, 2009 
declaration was made pursuant to section 564(b) of the Federal Food, 
Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b). In renewing this 
declaration, the Secretary further specified that the declaration is a 
declaration of emergency, as defined in the December 17, 2008 
Declaration under the Public Readiness and Emergency Preparedness Act 
for Influenza Diagnostics, Personal Respiratory Protection Devices, and 
Respiratory Support Devices, 73 FR 78362 (December 22, 2008).

    Dated: March 26, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-7529 Filed 4-1-10; 8:45 am]
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