Notification of a Cooperative Agreement Award to the World Health Organization, 49756-49757 [2013-19860]
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49756
Federal Register / Vol. 78, No. 158 / Thursday, August 15, 2013 / Notices
under Executive Order 12963, dated
June 14, 1993, and amended under
Executive Order 13009, dated June 14,
1995. PACHA is governed by the
provisions of the Federal Advisory
Committee Act (FACA), Public Law 92–
463, as amended (5 U.S.C. App.). The
Council provides advice, information,
and recommendations to the Secretary
regarding programs and policies to
promote effective prevention and cure
of HIV disease and AIDS. The functions
of the Council are solely advisory in
nature.
To carry out its mission, PACHA
provides advice, information, and
recommendations to the Secretary
regarding programs and policies to (a)
Reduce HIV incidence; (b) advance
research on HIV/AIDS; (c) improve
health outcomes and ensure people
living with HIV have access to quality
health care; (d) address HIV-related
health disparities; and (e) provide global
leadership in responding to the HIV
pandemic and expand access to
treatment, care, and prevention for
people infected with and affected by
HIV/AIDS around the world.
On July 26, 2013, the Secretary of
Health and Human Services approved
for the PACHA charter to be renewed.
One amendment was approved for the
charter. It was approved for the
subcommittee structure of the Council
to be amended to authorize utilization
of non-member special consultants. The
use of non-member special consultants
will allow for more input and
involvement from stakeholders in the
HIV/AIDS community in the PACHA
deliberative process. The new charter
was effected and filed with the
appropriate Congressional offices and
Library of Congress on July 27, 2013.
Renewal of the PACHA charter gives
authorization for the Council to
continue to operate until July 27, 2015.
A copy of the PACHA charter is
available on the Council Web site at
www.aids.gov/pacha. A copy of the
charter also can be obtained by
accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
Web site address for the FACA database
is www.fido.gov/facadatabase.
Dated: August 8, 2013.
B. Kaye Hayes,
Executive Director, Presidential Advisory
Council on HIV/AIDS.
[FR Doc. 2013–19781 Filed 8–14–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Renewal of Charter for the National
Vaccine Advisory Committee
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services is hereby giving notice
that the National Vaccine Advisory
Committee (NVAC) has been
rechartered.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
LCDR Guillermo Aviles-Mendoza,
Public Health Advisor, National Vaccine
Program Office, Department of Health
and Human Services, Room 739G.4,
Hubert H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201. Phone: (202)
205–2982; fax: (202) 690–4631; email:
nvpo@hhs.gov.
NVAC is a
non-discretionary Federal advisory
committee. The establishment of NVAC
was mandated under Section 2105 (42
U.S.C. Section 300aa–5) of the Public
Health Service (PHS) Act, as amended.
The Committee is governed by
provisions of the Federal Advisory
Committee Act (FACA), Public Law 92–
463, as amended (5 U.S.C. App.). NVAC
advises and makes recommendations to
the Director, National Vaccine Program
(NVP), on matters related to the
Program’s responsibilities. The
Assistant Secretary for Health is
appointed to serve as the Director, NVP.
To carry out its mission, NVAC (1)
Studies and recommends ways to
encourage the availability of an
adequate supply of safe and effective
vaccination products in the United
States; (2) recommends research
priorities and other measures the
Director of the NVP should take to
enhance the safety and efficacy of
vaccines; (3) advises the Director of the
NVP in the implementation of Sections
2102 and 2103 of the PHS Act; and (4)
identifies annually for the Director of
the NVP the most important areas of
governmental and non-governmental
cooperation that should be considered
in implementing Sections 2101 and
2103 of the PHS Act.
On July 23, 2013, the Assistant
Secretary for Health approved for the
NVAC charter to be renewed. There was
one amendment recommended and
approved for the charter. The
Committee structure has been modified
SUPPLEMENTARY INFORMATION:
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to increase the number of non-voting
liaison representatives. An invitation
has been extended to the Pan American
Health Organization (PAHO) to serve as
a non-voting liaison representative
member of the Committee. PAHO is an
international public health agency with
over 110 years of experience working to
improve health and living standards of
people of the Americas. The
organization is part of the United
Nations system; it serves as the Regional
Office for the Americas of the World
Health Organization and as the health
organization of the Inter-American
System. PAHO works to strengthen
national and local health systems and to
improve the health of peoples of the
Americas. It promotes primary health
care strategies, including coordination
of immunization campaigns through the
Americas. Expanding the NVAC
structure to include PAHO will assist
the Committee to accomplish its
mission of identifying the most
important areas of governmental and
non-governmental cooperation that
should be considered to achieve optimal
prevention of human infectious diseases
through immunization and to achieve
optimal prevention against adverse
reactions to vaccine. The new charter
was effected and filed with the
appropriate Congressional committees
and Library of Congress on July 30,
2013. Renewal of the NVAC charter
gives authorization for the Committee to
continue to operate until July 30, 2015.
A copy of the NVAC charter is
available on the Web site for the
National Vaccine Program Office at
https://www.hhs.gov/nvpo/nvac. A copy
of the charter also can be obtained by
accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
Web site address for the FACA database
is https://fido.gov/facadatabase.
Dated: August 8, 2013.
Bruce Gellin,
Deputy Assistant Secretary for Health
(Vaccines and Immunization), Director,
National Vaccine Program Office.
[FR Doc. 2013–19780 Filed 8–14–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notification of a Cooperative
Agreement Award to the World Health
Organization
Department of Health and
Human Services (HHS), Assistant
Secretary for Preparedness and
AGENCY:
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Federal Register / Vol. 78, No. 158 / Thursday, August 15, 2013 / Notices
emcdonald on DSK67QTVN1PROD with NOTICES
Response (ASPR), Biomedical Advanced
Research and Development Authority.
ACTION: Notification of a sole source
Cooperative Agreement Award to the
World Health Organization for a grant
titled: ‘‘Smallpox Research Oversight
Activities: WHO Advisory Committee
on Variola Virus Research.’’
Statutory Authority: Sections 301 and
319L of the Public Health Service Act,
(42 U.S.C. 241 and 247d–7e).
Estimated Amount of Award:
$290,000 USD.
Project Period: September 30, 2013 to
September 29, 2014.
SUMMARY: A natural re-emergence of
smallpox is not deemed possible, but if
it were to occur as a result of a terrorist
or deliberate event, it would be a
potentially devastating threat to public
health worldwide and would constitute
a public health emergency of
international concern (PHEIC) under the
International Health Regulations (IHR)
(2005). A case of smallpox detected by
a member state requires notification to
World Health Organization (WHO) as
soon as possible, and any confirmed
smallpox case would generate an
immediate global public health
response.
WHO must rely on fast and reliable
laboratory diagnostic capacity
worldwide to be able to identify a reemergence of smallpox, particularly in
countries where systemic orthopoxvirus
infections, such as monkeypox, vaccinia
virus infection or cowpox, and other
non-pox viral rash illnesses, such as
chicken pox, may cause clinical
diagnostic confusion.
Over the past 10 years, clinical
virology laboratory diagnostics has been
evolving and increasingly relies on
molecular techniques. This is also true
with laboratory diagnoses of poxvirus
infections. Precise and consistent
identification of orthopoxviruses, in
particular variola viruses, is now
achievable using such molecular
techniques as real-time Polymerase
Chain Reaction (PCR), unlike earlier
techniques that may have relied on
direct virus isolation and identification.
WHO must be alerted when there is
a potential or actual smallpox infection.
Early detection and confirmation of
smallpox cannot rely solely on the two
WHO Collaborating Centres for
smallpox and other poxvirus infections.
In order to facilitate and support a
prompt and effective response to
mitigate the spread of the disease, these
two Centres should be supported by a
worldwide network of reliable
laboratories able to perform PCR and
real-time PCR diagnostics enabling
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initial detection and identification of
smallpox events.
Additionally, the U.S. Government
supports the development of other
medical products, including vaccines
and drugs, for use within the U.S. upon
verification of a smallpox case. The U.S.
Government, through the Office of the
Assistant Secretary for Preparedness
and Response (ASPR), has successfully
developed vaccine products, and is
actively engaged in the development of
several drug candidates for smallpox
therapies, which require access to the
Variola virus to satisfy regulatory
requirements for product approvals.
Justification: WHO is the only eligible
applicant; it is the only organization
that is allowed by international
agreements to address the issues
outlined in this proposal. WHO is the
directing and coordinating authority for
health within the United Nations (U.N.)
system. It is responsible for providing
leadership on global health matters,
shaping the health research agenda,
setting norms and standards,
articulating evidence-based policy
options, providing technical support to
countries, and monitoring and assessing
health trends. In the 21st century, health
is a shared responsibility, involving
equitable access to essential care and
collective defense against transnational
threats. States Parties to the U.N. have
agreed to international standards on
reporting public health incidents of
concern under IHR (2005). Additionally,
a majority of States Parties have also
agreed to specific work-frames for
pathogens such as smallpox under the
Biological Weapons Convention.
Since May 1999, when the 52nd
World Health Assembly (WHA) resolved
to postpone the destruction of the
Variola virus to allow for essential
research (WHA 52.10), WHO has been
charged with convening a group of
experts to advise on the need for
continuing such research, to review
proposals for research involving viable
Variola virus, to review the progress of
such research, and to report to the WHA
each year. The need to support the
activities described in this project has
not changed. In fact, WHO Member
States continue to exert pressure for the
WHO Secretariat to carry out this work.
The WHO Advisory Committee on
Variola Virus Research (ACVVR) was
established in 1999 to determine what
essential research, if any, must be
carried out with live Variola virus. The
ACVVR monitored the research progress
in order to reach global consensus on
the timing for the destruction of existing
Variola virus stocks. In 2007, the WHA
requested the ACVVR undertake a
thorough review of the approved
PO 00000
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49757
research program with a report
presented in 2010. The results were
presented at the 64th WHA meeting in
May of 2011. The ACVVR continues to
serve a critically important function for
global public health, and to oversee
research requested specifically by the
U.S. to complete its national strategic
goals. This includes convening a group
of experts, the ACVVR, to advise on the
need for continuing such research, to
review proposals for research involving
viable Variola virus, and to review the
progress of such research.
Additional Information: The agency
program contact is George Korch, who
can be contacted by phone at (202) 690–
5760 or via email at
George.Korch@hhs.gov.
Dated: August 8, 2013.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2013–19860 Filed 8–14–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notification of an Expansion to the
Cooperative Agreement Award to the
World Health Organization
Biomedical Advanced Research
and Development Authority (BARDA),
Assistant Secretary for Preparedness
and Response (ASPR), Department of
Health and Human Services (HHS).
ACTION: Notification of an expansion to
the Cooperative Agreement Award to
the World Health Organization for a
grant titled: ‘‘Smallpox Research
Oversight Activities: WHO Advisory
Committee on Variola Virus Research’’
AGENCY:
Statutory Authority: Sections 301 and
319L of the Public Health Service Act, (42
U.S.C. 241 and 247d–7e)
Estimated Amount of Award:
$175,000 USD.
Project Period: September 30, 2012 to
September 29, 2013.
SUMMARY: A natural re-emergence of
smallpox is not deemed possible, but if
it were to occur as a result of a terrorist
or deliberate event, it would be a
potentially devastating threat to public
health worldwide and would constitute
a public health emergency of
international concern (PHEIC) under the
International Health Regulations (IHR)
(2005). A case of smallpox detected by
a member state requires notification to
World Health Organization (WHO) as
soon as possible, and any confirmed
smallpox case would generate an
E:\FR\FM\15AUN1.SGM
15AUN1
]]>Agencies
[Federal Register Volume 78, Number 158 (Thursday, August 15, 2013)]
[Notices]
[Pages 49756-49757]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19860]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Notification of a Cooperative Agreement Award to the World Health
Organization
AGENCY: Department of Health and Human Services (HHS), Assistant
Secretary for Preparedness and
[[Page 49757]]
Response (ASPR), Biomedical Advanced Research and Development
Authority.
ACTION: Notification of a sole source Cooperative Agreement Award to
the World Health Organization for a grant titled: ``Smallpox Research
Oversight Activities: WHO Advisory Committee on Variola Virus
Research.''
-----------------------------------------------------------------------
Statutory Authority: Sections 301 and 319L of the Public Health
Service Act, (42 U.S.C. 241 and 247d-7e).
Estimated Amount of Award: $290,000 USD.
Project Period: September 30, 2013 to September 29, 2014.
SUMMARY: A natural re-emergence of smallpox is not deemed possible, but
if it were to occur as a result of a terrorist or deliberate event, it
would be a potentially devastating threat to public health worldwide
and would constitute a public health emergency of international concern
(PHEIC) under the International Health Regulations (IHR) (2005). A case
of smallpox detected by a member state requires notification to World
Health Organization (WHO) as soon as possible, and any confirmed
smallpox case would generate an immediate global public health
response.
WHO must rely on fast and reliable laboratory diagnostic capacity
worldwide to be able to identify a re-emergence of smallpox,
particularly in countries where systemic orthopoxvirus infections, such
as monkeypox, vaccinia virus infection or cowpox, and other non-pox
viral rash illnesses, such as chicken pox, may cause clinical
diagnostic confusion.
Over the past 10 years, clinical virology laboratory diagnostics
has been evolving and increasingly relies on molecular techniques. This
is also true with laboratory diagnoses of poxvirus infections. Precise
and consistent identification of orthopoxviruses, in particular variola
viruses, is now achievable using such molecular techniques as real-time
Polymerase Chain Reaction (PCR), unlike earlier techniques that may
have relied on direct virus isolation and identification.
WHO must be alerted when there is a potential or actual smallpox
infection. Early detection and confirmation of smallpox cannot rely
solely on the two WHO Collaborating Centres for smallpox and other
poxvirus infections. In order to facilitate and support a prompt and
effective response to mitigate the spread of the disease, these two
Centres should be supported by a worldwide network of reliable
laboratories able to perform PCR and real-time PCR diagnostics enabling
initial detection and identification of smallpox events.
Additionally, the U.S. Government supports the development of other
medical products, including vaccines and drugs, for use within the U.S.
upon verification of a smallpox case. The U.S. Government, through the
Office of the Assistant Secretary for Preparedness and Response (ASPR),
has successfully developed vaccine products, and is actively engaged in
the development of several drug candidates for smallpox therapies,
which require access to the Variola virus to satisfy regulatory
requirements for product approvals.
Justification: WHO is the only eligible applicant; it is the only
organization that is allowed by international agreements to address the
issues outlined in this proposal. WHO is the directing and coordinating
authority for health within the United Nations (U.N.) system. It is
responsible for providing leadership on global health matters, shaping
the health research agenda, setting norms and standards, articulating
evidence-based policy options, providing technical support to
countries, and monitoring and assessing health trends. In the 21st
century, health is a shared responsibility, involving equitable access
to essential care and collective defense against transnational threats.
States Parties to the U.N. have agreed to international standards on
reporting public health incidents of concern under IHR (2005).
Additionally, a majority of States Parties have also agreed to specific
work-frames for pathogens such as smallpox under the Biological Weapons
Convention.
Since May 1999, when the 52nd World Health Assembly (WHA) resolved
to postpone the destruction of the Variola virus to allow for essential
research (WHA 52.10), WHO has been charged with convening a group of
experts to advise on the need for continuing such research, to review
proposals for research involving viable Variola virus, to review the
progress of such research, and to report to the WHA each year. The need
to support the activities described in this project has not changed. In
fact, WHO Member States continue to exert pressure for the WHO
Secretariat to carry out this work.
The WHO Advisory Committee on Variola Virus Research (ACVVR) was
established in 1999 to determine what essential research, if any, must
be carried out with live Variola virus. The ACVVR monitored the
research progress in order to reach global consensus on the timing for
the destruction of existing Variola virus stocks. In 2007, the WHA
requested the ACVVR undertake a thorough review of the approved
research program with a report presented in 2010. The results were
presented at the 64th WHA meeting in May of 2011. The ACVVR continues
to serve a critically important function for global public health, and
to oversee research requested specifically by the U.S. to complete its
national strategic goals. This includes convening a group of experts,
the ACVVR, to advise on the need for continuing such research, to
review proposals for research involving viable Variola virus, and to
review the progress of such research.
Additional Information: The agency program contact is George Korch,
who can be contacted by phone at (202) 690-5760 or via email at
George.Korch@hhs.gov.
Dated: August 8, 2013.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2013-19860 Filed 8-14-13; 8:45 am]
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