Determination and Declarations Regarding Emergency Use of Certain In vitro Diagnostic, Antiviral, and Personal Respiratory Products Accompanied by Emergency Use Information, 38628-38630 [E9-18432]
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38628
Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
It is further ordered that the
Commission’s Bureau of Enforcement be
made a party to this proceeding;
It is further ordered that rebuttal
affidavits and memoranda of law shall
be filed by the Bureau of Enforcement
and any intervenors in opposition to the
Respondent no later than October 5,
2009;
It is further ordered that reply
affidavits and memoranda of law shall
be filed by the Respondent and
intervenors in support no later than
October 20, 2009;
It is further ordered that:
(a) Should any party believe that an
evidentiary hearing is required, that
party must submit a request for such a
hearing together with a statement setting
forth in detail the facts to be proved, the
relevance of those facts to the issues in
this proceeding, a description of the
evidence which would be adduced, and
why such evidence cannot be submitted
by affidavit;
(b) Should any party believe that an
oral argument is required, that party
must submit a request specifying the
reasons therefor and why argument by
memorandum is inadequate to present
the party’s case; and
(c) Any request for evidentiary
hearing or oral argument shall be filed
no later than October 5, 2009;
It is further ordered that notice of this
proceeding be published in the Federal
Register and that a copy thereof be
served upon Respondent at his last
known address;
It is further ordered that all
documents submitted by any party of
record in this proceeding shall be filed
in accordance with Rule 118 of the
Commission’s Rules of Practice and
Procedure, 46 CFR 502.118, as well as
being mailed directly to all parties of
record;
Finally, it is ordered that pursuant to
the terms of Rule 61 of the
Commission’s Rules of Practice and
Procedure, 46 CFR 502.61, the final
decision of the Commission in this
proceeding shall be issued by February
17, 2010.
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By the Commission.
Karen V. Gregory,
Secretary.
[FR Doc. E9–18601 Filed 8–3–09; 8:45 am]
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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.
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
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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
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
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® (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®
(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
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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 nonpowered 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.
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.
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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38629
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
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38630
Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
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
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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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Office for Civil Rights; Delegation of
Authority
Notice is hereby given, that I have
delegated to the Director of the Office
for Civil Rights (OCR), with authority to
redelegate, the following authority
vested in the Secretary of Health and
Human Services:
1. The authority under section 262 of
the Health Insurance Portability and
Accountability Act of 1996 (HIPAA),
Public Law 104–191, as amended, to the
extent that these actions pertain to the
‘‘Security Standards for the Protection
of Electronic Protected Health
Information,’’ at 45 CFR part 160 and
part 164, subparts A and C, to
A. Impose civil money penalties
under section 1176 of the Social
Security Act for a covered entity’s
failure to comply with certain
requirements and standards;
B. Issue subpoenas requiring the
attendance and testimony of witnesses
and the production of any evidence that
relates to any matter under investigation
or compliance review for failure to
comply with certain requirements and
standards; and
C. Make exception determinations,
under section 1178(a)(2)(A) of the Social
Security Act, concerning when
provisions of State laws that are
contrary to the Federal standards are not
preempted by the Federal provisions.
2. The authority under section 262 of
HIPAA, as amended, to administer the
regulation ‘‘Security Standards for the
Protection of Electronic Protected
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Health Information,’’ at 45 CFR part 160
and part 164, subparts A and C, and
General Administrative Requirements,
45 CFR Part 160, as these requirements
pertain to part 164, subparts A and C,
and to make decisions regarding the
interpretation and enforcement of these
Standards and General Administrative
Requirements.
This delegation shall be exercised
under the Department’s existing
delegation of authority and policy
relating to regulations.
This delegation supersedes the
memorandum from the Secretary to the
Administrator, Centers for Medicare &
Medicaid Services, dated October 7,
2003, titled ‘‘Delegation of Authority for
Certain Provisions Under Part C of Title
XI of the Social Security Act.’’
I hereby affirm and ratify any actions
taken by the Director of OCR or his/her
subordinates which involved the
exercise of the authority delegated
herein prior to the effective date of this
delegation.
This delegation is effective
immediately.
Dated: July 27, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9–18557 Filed 8–3–09; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Implementation of Section 5001 of the
American Recovery and Reinvestment
Act of 2009 (ARRA) for Adjustments to
the Third Quarter of Fiscal Year 2009
Federal Medical Assistance
Percentage (FMAP) Rates for Federal
Matching Shares for Medicaid and
Foster Care and Adoption Assistance
Office of the Secretary, DHHS.
Notice with comment period.
AGENCY:
ACTION:
SUMMARY: This notice with comment
period describes the methodology for
calculating the higher federal matching
funding that is made available under
Section 5001 of the American Recovery
and Reinvestment Act of 2009 (ARRA).
Section 5001 of the ARRA provides for
temporary increases in the Federal
Medical Assistance Percentage (FMAP)
rates to provide fiscal relief to States
and to protect and maintain State
Medicaid programs in a period of
economic downturn. The increased
FMAP rates apply during a recession
adjustment period that is defined as the
period beginning on October 1, 2008
and ending on December 31, 2010.
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]]>Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38628-38630]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18432]
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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.
-----------------------------------------------------------------------
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]
BILLING CODE 4150-37-P
