[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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