4 August 2009

Related:

fda080409.htm         FDA Emergency Use of H1N1 Flu Antiviral Drugs    August 4, 2009
fda080409-2.htm       FDA Emergency Use of H1N1 Flu Respiratory Aids   August 4, 2009
fda080409-3.htm       FDA Emergency Use of H1N1 Flu In Vitro Devices   August 4, 2009

[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]               
[Page 38628-38630]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au09-48]                         

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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 
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 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 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.

DATES: The declaration of an emergency justifying the authorization of 
emergency use of certain in vitro diagnostic products is effective 
April 26, 2009. The declaration of an emergency justifying the 
authorization of certain antiviral products is effective April 26, 
2009. The declaration of an emergency justifying the authorization of 
emergency use of certain respiratory protection products is effective 
April 27, 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 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 Acting Secretary of 
HHS and the declarations of an emergency by the Acting Secretary of HHS 
based on that determination, as described below, enabled the Acting 
Commissioner to issue EUAs for certain in vitro diagnostic, antiviral, 
and personal respiratory protection products

[[Page 38629]]

for emergency use under section 564(a) of the FFDCA, 21 U.S.C. 360bbb-
3(a).
    An in vitro diagnostic, CDC Human Influenza Virus Real-time RT-PCR 
Detection and Characterization Panel (rRT-PCR Flu Panel), is cleared by 
FDA for detection of seasonal Influenza A and subtype determination. 
CDC sought an EUA to allow this test to be used with specimen types and 
reagents additional to those of the cleared test as a first tier test 
for patients suspected of having 2009-H1N1 influenza. CDC also sought 
an EUA to allow an in vitro diagnostic that has not been previously 
approved or cleared by the FDA, Swine Influenza Virus Real-time RT-PCR 
Detection Panel (rRT-PCR Swine Flu Panel), to be used in detecting 
2009-H1N1 influenza.
    CDC also sought EUAs for certain antiviral drug products, which are 
approved by FDA for use in treatment and prophylaxis of influenza for 
adult and pediatric use. Relenza[reg] (zanamivir) is approved to treat 
acute uncomplicated illnesses due to influenza in adults and children 7 
years and older who have been symptomatic for less than two days, and 
for the prevention of influenza in adults and children 5 years and 
older. Tamiflu[reg] (oseltamivir phosphate) is approved for the 
treatment of acute uncomplicated illness due to influenza in patients 1 
year and older who have been symptomatic for less than two days, and 
for the prevention of influenza in patients 1 year and older. The EUA 
for Tamiflu allows for Tamiflu to also be used to treat and prevent 
influenza in children under one year, to treat influenza in patients 
who have been symptomatic for more than 2 days, and to provide 
alternate dosing recommendations for certain pediatric populations. The 
EUA for Tamiflu also authorizes distribution of Tamiflu deployed from 
the Strategic National Stockpile (SNS) and that has had its expiration 
date extended under the Federal government's Shelf Life Extension 
Program (SLEP). In addition, under the EUAs, both Tamiflu and Relenza 
may be distributed to large segments of the population without 
complying with certain prescription label requirements otherwise 
applicable to dispensed drug. Under the EUAs, Tamiflu and Relenza are 
authorized to be accompanied by certain written information pertaining 
to the emergency. The EUAs note that there may be distribution of these 
products by a broader range of health care workers, including some 
public health officials and volunteers, in accordance with applicable 
State and local laws and/or the public health and medical emergency 
response of the authority having jurisdiction, subject to the terms and 
conditions of the EUA.
    Finally, certain personal respiratory protection devices certified 
by the National Institute for Occupational Safety and Health (NIOSH), 
in accordance with 42 CFR part 84, as non-powered air-purifying 
particulate respirators with a minimum filtration efficiency 
classification of N95 (known as N95 respirators) have been cleared by 
FDA for use by the general public in public health medical emergencies, 
such as an influenza pandemic. Other N95 respirators have been cleared 
by FDA for use in certain workplace settings. The disposable N95 
respirators for which CDC sought an EUA were either not previously 
cleared or approved by FDA or were cleared by FDA but only for use in 
certain workplace settings. The EUA authorized the emergency use, by 
the general public,\1\ of these products, as deployed from the SNS and 
accompanied by emergency use information, to help reduce wearer 
exposure to airborne germs during this emergency. The specific products 
covered by the EUA are identified in the EUA by manufacturer and model 
number; fifteen different models of disposable N95 respirators are 
covered.
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    \1\ For purposes of this EUA, the term ``general public'' is 
broad and includes people performing work-related duties. This EUA 
affects only requirements applicable under the Federal Food, Drug, 
and Cosmetic Act. It does not affect requirements arising from other 
sources of law, such as Occupational Safety and Health 
Administration (OSHA) requirements.
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    With issuance of the EUAs for certain in vitro diagnostic products, 
laboratories may receive certain in vitro diagnostics covered by the 
EUAs for use in detection of 2009-H1N1 influenza, and patients and 
health care professionals may receive emergency use information 
regarding these in vitro diagnostic products during this public health 
emergency involving 2009-H1N1 influenza. With issuance of the EUAs for 
certain antiviral products and issuance of the EUA for certain personal 
respiratory products, members of the general public may receive certain 
antiviral and personal respiratory protection products covered by the 
EUAs, accompanied by emergency use information, for immediate use by 
them during this 2009-H1N1 influenza emergency. These products and 
accompanying information may help to detect the spread of 2009-H1N1 
influenza, protect individuals against contracting 2009-H1N1 influenza, 
and treat individuals who are ill following exposure to 2009-H1N1 
influenza.
    In this public health emergency involving 2009-H1N1 influenza, time 
is 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 distributing certain in vitro diagnostic 
products accompanied by emergency use information, public health and 
health care professionals can ensure that 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 those who may have been 
exposed or are ill, accompanied by the information most important to 
their emergency use.
    This is one part of the Federal Government's strategy to encourage 
preparedness at all levels of government to enable the nation to 
respond effectively in response to this public health emergency.

II. Determination of the Acting 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 (swH1N1) (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.

III. Declarations of the Acting Secretary of Health and Human Services

    On April 26, 2009, on the basis of the Acting Secretary's 
determination on April 26, 2009, pursuant to section 319 of the Public 
Health Service Act, 42 U.S.C. 247d, that a public health emergency 
exists involving 2009-H1N1 influenza that affects or has significant

[[Page 38630]]

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), the 
Acting Secretary declared 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). The Secretary further specified 
that the declaration is a declaration of emergency, as defined in the 
December 17, 2008, Declaration under the PREP Act for Pandemic 
Influenza Diagnostics, Personal Respiratory Protection Devices, and 
Respiratory Support Devices, published at 73 FR 78362 (December 22, 
2008).
    Also, on April 26, 2009, on the basis of the Acting Secretary's 
determination on April 26, 2009, pursuant to section 319 of the Public 
Health Service Act, 42 U.S.C. 247d, that a public health emergency 
exists involving Swine Influenza A 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), the 
Acting Secretary declared 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). The Secretary further specified that the 
declaration is a declaration of emergency, as defined in the October 
10, 2008, Declaration under the PREP Act for Influenza Antivirals 
Oseltamivir Phosphate and Zanamivir, published at 73 FR 61861 (October 
17, 2008), as amended. The Acting Secretary's April 26, 2009, amendment 
to the October 10, 2008 Declaration under the PREP Act for Influenza 
Antivirals Oseltamivir Phosphate and Zanamivir is separately published 
elsewhere in this issue of the Federal Register.
    On April 27, 2009, on the basis of the Acting Secretary's 
determination on April 26, 2009, pursuant to section 319 of the Public 
Health Service Act, 42 U.S.C. 247d, that a public health emergency 
exists involving Swine Influenza A 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), the 
Acting Secretary declared an emergency justifying the authorization of 
the emergency use of 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). The Secretary further 
specified that the declaration is a declaration of emergency, as 
defined in the December 17, 2008, Declaration under the PREP Act for 
Pandemic Influenza Diagnostics, Personal Respiratory Protection 
Devices, and Respiratory Support Devices, 73 FR 78362 (December 22, 
2008).
    Notice of the authorizations issued by the FDA Commissioner under 
21 U.S.C. 360bbb-3 is provided elsewhere in this Federal Register.

    Dated: July 28, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-18432 Filed 8-3-09; 8:45 am]

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