Determination and Declarations Regarding Emergency Use of Certain In vitro Diagnostic, Antiviral, and Personal Respiratory Products Accompanied by Emergency Use Information, 16810-16812 [2010-7529]
Download as PDF
<![CDATA[
16810
Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Notices
to the OS Paperwork Clearance Officer
at the above e-mail address within 60
days.
Proposed Project: Application for
Waiver of the 2-Year Foreign Residence
Requirement of the Exchange Visitor
Waiver Program, OMB No. 0990–0001—
Extension, Office of the Secretary, Office
of Global Health Affairs.
published regulations, as to whether or
not to request from the Department of
State, a waiver of the two-year foreign
residence requirement for applicants in
the United States on a J–1 visa. The type
of respondent is voluntary; the affected
public is business for profit, not-for
profit institutions, Federal Government,
State, Local or Tribal Government
Abstract: The Office of Global Health
Affairs is requesting an extension on a
previous approved collection OMB
#0990–0001—Application for Waiver of
the 2-Year Foreign Residence
Requirement of the Exchange Visitor
Waiver Program. This form and
supplementary information sheets is
used by this Department to make a
determination, in accordance with its
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
responses per
respondent
Type of
respondent
HHS–426 ..........................................
HHS–426 ..........................................
Research Applications ......................
Clinical Care Research ....................
150
50
1
1
10
10
1500
500
Total ...........................................
...........................................................
........................
........................
........................
2000
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2010–7445 Filed 4–1–10; 8:45 am]
BILLING CODE 4150–38–P
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.
mstockstill on DSKH9S0YB1PROD with NOTICES
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 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.
VerDate Nov<24>2008
16:40 Apr 01, 2010
Jkt 220001
Number of
respondents
Average
burden hours
per response
Forms
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.
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
Total burden
hours
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
E:\FR\FM\02APN1.SGM
02APN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Notices
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
VerDate Nov<24>2008
16:40 Apr 01, 2010
Jkt 220001
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
PO 00000
Frm 00093
Fmt 4703
Sfmt 4703
16811
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
E:\FR\FM\02APN1.SGM
02APN1
16812
Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Notices
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]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Multiplier Surveys—
NEW
While all SAMHSA programming is
intended to support the SAMHSA
vision of a life in the community for
everyone, and its strategic goals of
accountability, capacity, and
Number of
respondents
Information source
Responses
per
respondent
effectiveness, there has been little
systematic investigation of the longrange impact of different categories of
discretionary programs. The Multiplier
Surveys will inform SAMHSA policy
and budget development by determining
which types of investments are most
appropriate for achieving different
policy objectives, including
sustainability of the program or its
intended outcomes after Federal
funding ends. It also seeks to determine
which program types or factors are best
at achieving certain objectives after the
conclusion of Federal funding, such as
capacity improvement, system change,
sustainability and influence on other
programs. Findings will be used to make
recommendations to SAMHSA
management to better inform policy and
budget development and to determine
which types of investments are most
appropriate for achieving different
policy objectives.
To achieve the goals of the Multiplier
Surveys four programs have been
chosen from each of SAMHSA’s three
Centers. Four Project Directors from
each of the 12 programs (48 respondents
in all), whose Federal funding ended no
later than September 30, 2008 will be
interviewed by telephone to determine
how the project was sustained after
Federal funding ended and what factors
contributed to its sustainability.
In addition, all grantees from each of
the 12 selected programs meeting
inclusion criteria will be invited via email to complete a short on-line survey
about their project and how/if it was
sustained after Federal funding ended.
A 20 percent response rate or about 100
respondents to the on-line survey is
expected.
The estimated response burden is as
follows:
Total
responses
Hours per
response
Total hours
48
100
1
1
48
100
1.25
.75
60
75
Total ..............................................................................
mstockstill on DSKH9S0YB1PROD with NOTICES
Project Director ....................................................................
Web-based Survey ..............................................................
148
........................
148
........................
135
VerDate Nov<24>2008
16:40 Apr 01, 2010
Jkt 220001
PO 00000
Frm 00094
Fmt 4703
Sfmt 9990
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 75, Number 63 (Friday, April 2, 2010)]
[Notices]
[Pages 16810-16812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7529]
-----------------------------------------------------------------------
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
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]
BILLING CODE 4150-37-P
