Declaration That Circumstances Exist Justifying Authorization of Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information, 40479-40480 [2013-16177]
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Federal Register / Vol. 78, No. 129 / Friday, July 5, 2013 / Notices
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tkelley on DSK3SPTVN1PROD with NOTICES
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17:06 Jul 03, 2013
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VerDate Mar<15>2010
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maintained and third-party applications
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contribute information to his or her
account.
[FR Doc. 2013–16124 Filed 7–3–13; 8:45 am]
BILLING CODE 6820–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Declaration That Circumstances Exist
Justifying Authorization of Emergency
Use of All Oral Formulations of
Doxycycline Accompanied by
Emergency Use Information
Office of the Secretary (OS),
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Secretary of Homeland
Security determined on September 23,
2008, that there is a significant potential
for a domestic emergency involving a
heightened risk of attack with a
specified biological, chemical,
radiological, or nuclear agent or
agents—in this case, Bacillus
anthracis—pursuant to section
564(b)(1)(A) of the Federal Food, Drug,
and Cosmetic (FD&C) Act.1 On the basis
of that determination, and pursuant to
section 564(b) of the FD&C Act, the
Secretary of Health and Human Services
(HHS) is declaring that circumstances
exist justifying the authorization of
emergency use of all oral formulations
of doxycycline accompanied by
emergency use information subject to
the terms of any authorization issued by
the Commissioner of Food and Drugs
under section 564(a) of the FD&C Act.
This notice is being issued in
accordance with section 564(b)(4) of the
FD&C Act.
DATES: This Notice and referenced HHS
declaration are effective as of June 27,
2013.
FOR FURTHER INFORMATION CONTACT:
Nicole Lurie, MD, 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:
SUMMARY:
I. Background
On September 23, 2008, former
Secretary of Homeland Security,
1 Section 564 of the FD&C Act is codified at 21
U.S.C. 360bbb–3.
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05JYN1
40480
Federal Register / Vol. 78, No. 129 / Friday, July 5, 2013 / Notices
Michael Chertoff, determined, pursuant
to section 564(b)(1)(A) of the FD&C Act,
that there is a significant potential for a
domestic emergency involving a
heightened risk of attack with a
specified biological, chemical,
radiological, or nuclear agent or
agents—in this case, Bacillus
anthracis—although there is no current
domestic emergency involving anthrax,
no current heightened risk of an anthrax
attack, and no credible information
indicating an imminent threat of an
attack involving Bacillus anthracis. On
October 1, 2008, on the basis of that
determination, and pursuant to section
564(b) of the FD&C Act, former HHS
Secretary, Michael O. Leavitt, declared
an emergency justifying the emergency
use of doxycycline hyclate tablets
accompanied by emergency use
information subject to the terms of any
authorization issued under section
564(a) of the FD&C Act.2 On October 1,
2009 and October 1, 2010, I renewed the
former Secretary’s declaration,3 and on
July 20, 2011, I renewed and amended
the declaration to declare that the
emergency justifies emergency use of all
oral formulations of doxycycline
accompanied by emergency use
information subject to the terms of any
authorization issued under section
564(a) of the FD&C Act.4 On June 28,
2012, I renewed my July 20, 2011
declaration.5
II. Declaration of the Secretary of
Health and Human Services
tkelley on DSK3SPTVN1PROD with NOTICES
On the basis of the September 23,
2008 determination by the Secretary of
Homeland Security and pursuant to
section 564(b) of the FD&C Act, I hereby
declare that circumstances exist
justifying the authorization of
emergency use of all oral formulations
of doxycycline accompanied by
emergency use information subject to
the terms of any authorization issued
under section 564(a) of the FD&C Act.6
2 Pursuant to section 564(b)(4) of the FD&C Act,
notice of the determination by the Secretary of
Homeland Security and the declaration by the HHS
Secretary was provided at 73 FR 58242 (October 6,
2008).
3 Pursuant to section 564(b)(4) of the FD&C Act,
notices of the renewals of the declaration of the
HHS Secretary were provided at 74 FR 51,279 (Oct.
6, 2009) and 75 FR 61,489 (Oct. 5, 2010).
4 Pursuant to section 564(b)(4) of the FD&C Act,
notice of the renewal and amendment of the
declaration of the HHS Secretary was provided at
76 FR 44,926 (July 27, 2011).
5 Pursuant to section 564(b)(4) of the FD&C Act,
notice of the renewal of the declaration of the HHS
Secretary was provided at 77 FR 39,708 (July 5,
2012).
6 Section 564(b)(1) of the FD&C Act was amended
by section 302 of the Pandemic and All-Hazards
Preparedness Reauthorization Act, Public Law 113–
5, to provide that the HHS Secretary may ‘‘make a
VerDate Mar<15>2010
17:06 Jul 03, 2013
Jkt 229001
I am issuing this notice in accordance
with section 564(b)(4) of the FD&C Act.
Dated: June 27, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013–16177 Filed 7–3–13; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board;
Call for Nominees
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The deadline for all
application submissions to the National
Biodefense Science Board (NBSB) is
extended from July 7, 2013, to August
4, 2013 at 11:59 p.m. The Office of the
Secretary is accepting application
submissions from qualified individuals
who wish to be considered for
membership on the NBSB; six members
have membership expiration dates of
December 31, 2013, therefore, six new
voting members will be selected for the
Board. Nominees are being accepted in
the following categories: Industry,
Academia, Healthcare Consumer
Organizations, and Organizations
Representing Other Appropriate
Stakeholders. Please visit the NBSB
Web site at www.phe.gov/nbsb for all
application submission information and
instructions. All members of the public
are encouraged to apply.
FOR FURTHER INFORMATION CONTACT:
CAPT Charlotte Spires, DVM, MPH,
DACVPM, Executive Director and
Designated Federal Official, National
Biodefense Science Board, Office of the
Assistant Secretary for Preparedness
and Response, U.S. Department of
Health and Human Services, Thomas P.
O’Neill Federal Building, Room number
14F18, 200 C St. SW., Washington, DC
20024; Office: 202–260–0627, Email
address: charlotte.spires@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to section 319M of the Public Health
Service Act (42 U.S.C. 247d–7f) and
section 222 of the Public Health Service
Act (42 U.S.C. 217a), the Department of
SUMMARY:
declaration that the circumstances exist justifying
the authorization’’ for a product under section 564
of the FD&C Act on the basis of one of four
determinations specified under subsection 564(b)(1)
of the FD&C Act, including a determination by the
Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for
a domestic emergency, involving a heightened risk
of attack with a chemical, biological, radiological,
or nuclear agent or agents.
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Fmt 4703
Sfmt 4703
Health and Human Services established
the National Biodefense Science Board.
The Board shall provide expert advice
and guidance to the Secretary on
scientific, technical, and other matters
of special interest to the Department of
Health and Human Services regarding
current and future chemical, biological,
nuclear, and radiological agents,
whether naturally occurring, accidental,
or deliberate. The Board may also
provide advice and guidance to the
Secretary and/or the Assistant Secretary
for Preparedness and Response (ASPR)
on other matters related to public health
emergency preparedness and response.
Description of Duties: The Board shall
advise the Secretary and/or ASPR on
current and future trends, challenges,
and opportunities presented by
advances in biological and life sciences,
biotechnology, and genetic engineering
with respect to threats posed by
naturally occurring infectious diseases
and chemical, biological, radiological,
and nuclear agents. At the request of the
Secretary and/or ASPR, the Board shall
review and consider any information
and findings received from the working
groups established under 42 U.S.C.
247d–7f(b). At the request of the
Secretary and/or ASPR, the Board shall
provide recommendations and findings
for expanded, intensified, and
coordinated biodefense research and
development activities. Additional
advisory duties concerning public
health emergency preparedness and
response may be assigned at the
discretion of the Secretary and/or ASPR.
Structure: The Board shall consist of
13 voting members, including the
Chairperson; additionally, there may be
non-voting ex officio members. Pursuant
to 42 U.S.C. 247d–7f(a), members and
the chairperson shall be appointed by
the Secretary from among the Nation’s
preeminent scientific, public health and
medical experts, as follows: (a) Such
federal officials as the Secretary
determines are necessary to support the
functions of the Board, (b) four
individuals from the pharmaceutical,
biotechnology and device industries, (c)
four academicians, and (d) five other
members as determined appropriate by
the Secretary and/or ASPR, one of
whom must be a practicing health care
professional, one of whom must be from
an organization representing health care
consumers, one of whom must have
pediatric subject matter expertise, and
one of whom shall be a State, tribal,
territorial, or local public health official.
Additional members for category (d),
above, will be selected from among
emergency medical responders and
organizations representing other
appropriate stakeholders. A member of
E:\FR\FM\05JYN1.SGM
05JYN1
]]>Agencies
[Federal Register Volume 78, Number 129 (Friday, July 5, 2013)]
[Notices]
[Pages 40479-40480]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16177]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Declaration That Circumstances Exist Justifying Authorization of
Emergency Use of All Oral Formulations of Doxycycline Accompanied by
Emergency Use Information
AGENCY: Office of the Secretary (OS), Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary of Homeland Security determined on September 23,
2008, that there is a significant potential for a domestic emergency
involving a heightened risk of attack with a specified biological,
chemical, radiological, or nuclear agent or agents--in this case,
Bacillus anthracis--pursuant to section 564(b)(1)(A) of the Federal
Food, Drug, and Cosmetic (FD&C) Act.\1\ On the basis of that
determination, and pursuant to section 564(b) of the FD&C Act, the
Secretary of Health and Human Services (HHS) is declaring that
circumstances exist justifying the authorization of emergency use of
all oral formulations of doxycycline accompanied by emergency use
information subject to the terms of any authorization issued by the
Commissioner of Food and Drugs under section 564(a) of the FD&C Act.
This notice is being issued in accordance with section 564(b)(4) of the
FD&C Act.
---------------------------------------------------------------------------
\1\ Section 564 of the FD&C Act is codified at 21 U.S.C. 360bbb-
3.
DATES: This Notice and referenced HHS declaration are effective as of
---------------------------------------------------------------------------
June 27, 2013.
FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, 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
On September 23, 2008, former Secretary of Homeland Security,
[[Page 40480]]
Michael Chertoff, determined, pursuant to section 564(b)(1)(A) of the
FD&C Act, that there is a significant potential for a domestic
emergency involving a heightened risk of attack with a specified
biological, chemical, radiological, or nuclear agent or agents--in this
case, Bacillus anthracis--although there is no current domestic
emergency involving anthrax, no current heightened risk of an anthrax
attack, and no credible information indicating an imminent threat of an
attack involving Bacillus anthracis. On October 1, 2008, on the basis
of that determination, and pursuant to section 564(b) of the FD&C Act,
former HHS Secretary, Michael O. Leavitt, declared an emergency
justifying the emergency use of doxycycline hyclate tablets accompanied
by emergency use information subject to the terms of any authorization
issued under section 564(a) of the FD&C Act.\2\ On October 1, 2009 and
October 1, 2010, I renewed the former Secretary's declaration,\3\ and
on July 20, 2011, I renewed and amended the declaration to declare that
the emergency justifies emergency use of all oral formulations of
doxycycline accompanied by emergency use information subject to the
terms of any authorization issued under section 564(a) of the FD&C
Act.\4\ On June 28, 2012, I renewed my July 20, 2011 declaration.\5\
---------------------------------------------------------------------------
\2\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the
determination by the Secretary of Homeland Security and the
declaration by the HHS Secretary was provided at 73 FR 58242
(October 6, 2008).
\3\ Pursuant to section 564(b)(4) of the FD&C Act, notices of
the renewals of the declaration of the HHS Secretary were provided
at 74 FR 51,279 (Oct. 6, 2009) and 75 FR 61,489 (Oct. 5, 2010).
\4\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the
renewal and amendment of the declaration of the HHS Secretary was
provided at 76 FR 44,926 (July 27, 2011).
\5\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the
renewal of the declaration of the HHS Secretary was provided at 77
FR 39,708 (July 5, 2012).
---------------------------------------------------------------------------
II. Declaration of the Secretary of Health and Human Services
On the basis of the September 23, 2008 determination by the
Secretary of Homeland Security and pursuant to section 564(b) of the
FD&C Act, I hereby declare that circumstances exist justifying the
authorization of emergency use of all oral formulations of doxycycline
accompanied by emergency use information subject to the terms of any
authorization issued under section 564(a) of the FD&C Act.\6\ I am
issuing this notice in accordance with section 564(b)(4) of the FD&C
Act.
---------------------------------------------------------------------------
\6\ Section 564(b)(1) of the FD&C Act was amended by section 302
of the Pandemic and All-Hazards Preparedness Reauthorization Act,
Public Law 113-5, to provide that the HHS Secretary may ``make a
declaration that the circumstances exist justifying the
authorization'' for a product under section 564 of the FD&C Act on
the basis of one of four determinations specified under subsection
564(b)(1) of the FD&C Act, including a determination by the
Secretary of Homeland Security that there is a domestic emergency,
or a significant potential for a domestic emergency, involving a
heightened risk of attack with a chemical, biological, radiological,
or nuclear agent or agents.
Dated: June 27, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-16177 Filed 7-3-13; 8:45 am]
BILLING CODE 4150-37-P
