Single Source Cooperative Agreement Award for World Health Organization, 57567-57568 [2012-23017]
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Federal Register / Vol. 77, No. 181 / Tuesday, September 18, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HIT Policy Committee Advisory
Meeting; Notice of Meeting
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meeting.
AGENCY:
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This notice announces a forthcoming
meeting of a public advisory committee
of the Office of the National Coordinator
for Health Information Technology
(ONC). The meeting will be open to the
public.
Name of Committee: HIT Policy
Committee.
General Function of the Committee: To
provide recommendations to the National
Coordinator on a policy framework for the
development and adoption of a nationwide
health information technology infrastructure
that permits the electronic exchange and use
of health information as is consistent with
the Federal Health IT Strategic Plan and that
includes recommendations on the areas in
which standards, implementation
specifications, and certification criteria are
needed.
Date and Time: The meeting will be held
on October 3, 2012, from 10 a.m. to 3 p.m./
Eastern Time.
Location: The Dupont Circle Hotel, 1500
New Hampshire Avenue NW., Washington
DC 20036. For up-to-date information, go to
the ONC Web site, https://healthit.hhs.gov
Contact Person: MacKenzie Robertson,
Office of the National Coordinator, HHS, 355
E Street SW., Washington, DC 20201, 202–
205–8089, Fax: 202–260–1276, email:
mackenzie.robertson@hhs.gov. Please call the
contact person for up-to-date information on
this meeting. A notice in the Federal Register
about last minute modifications that impact
a previously announced advisory committee
meeting cannot always be published quickly
enough to provide timely notice.
Agenda: The committee will hear reports
from its workgroups and updates from ONC
and other Federal agencies. ONC intends to
make background material available to the
public no later than two (2) business days
prior to the meeting. If ONC is unable to post
the background material on its Web site prior
to the meeting, it will be made publicly
available at the location of the advisory
committee meeting, and the background
material will be posted on ONC’s Web site
after the meeting, at https://healthit.hhs.gov
Procedure: ONC is committed to the
orderly conduct of its advisory committee
meetings. Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
Committee. Written submissions may be
made to the contact person on or before two
days prior to the Committee’s meeting date.
Oral comments from the public will be
scheduled in the agenda. Time allotted for
each presentation will be limited to three
minutes. If the number of speakers requesting
to comment is greater than can be reasonably
accommodated during the scheduled public
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comment period, ONC will take written
comments after the meeting until close of
business on that day.
Persons attending ONC’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
ONC welcomes the attendance of the
public at its advisory committee meetings.
Seating is limited at the location, and ONC
will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact MacKenzie
Robertson at least seven (7) days in advance
of the meeting.
Notice of this meeting is given under the
Federal Advisory Committee Act (Pub. L. 92–
463, 5 U.S.C., App. 2).
Dated: September 11, 2012.
MacKenzie Robertson,
FACA Program Lead, Office of Policy and
Planning, Office of the National Coordinator
for Health Information Technology.
[FR Doc. 2012–22988 Filed 9–17–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Single Source Cooperative Agreement
Award for World Health Organization
Department of Health and
Human Services (HHS), Assistant
Secretary for Preparedness and
Response (ASPR).
ACTION: Notification of Single Source
Cooperative Agreement Award for
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:
$400,000.
Project Period: Sept. 30, 2012 to Sept.
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
immediate global public health
response.
WHO must rely on fast and reliable
laboratory diagnostic capacity
worldwide to be able to identify a re-
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57567
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 rely 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 (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.
Single Source 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 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
E:\FR\FM\18SEN1.SGM
18SEN1
57568
Federal Register / Vol. 77, No. 181 / Tuesday, September 18, 2012 / Notices
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 the development of
new antiviral agents, safer vaccines, and
better diagnostics, thus strengthening
our national security.
Additional Information: The agency
program contact is Richard J. Hatchett,
MD, who can be contacted by phone at
(202) 260–0150 or via email at
Richard.Hatchett@hhs.gov.
Dated: September 12, 2012.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
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[FR Doc. 2012–23017 Filed 9–17–12; 8:45 am]
BILLING CODE 4150–37–P
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18:39 Sep 17, 2012
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0386]
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of May 3, 2012 (77 FR 26281).
The document announced an
opportunity for public comment on the
proposed extension of an existing
collection of information by the Agency
pertaining to registration and product
listing for owners and operators of
domestic tobacco product
establishments and to listing of
ingredients in tobacco products under
the Family Smoking Prevention and
Tobacco Control Act. The document
published with incorrect FDA form
numbers. This document corrects those
errors.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2012–10645 appearing on page 26281 in
the Federal Register of Thursday, May
3, 2012, the following corrections are
made:
1. On page 26282, in the third
column, in the first full paragraph, the
fifth sentence ‘‘FDA also developed
paper forms (Form FDA 3742—
Registration and Listing for Owners and
Operators of Domestic Tobacco Product
Establishments and Form FDA 3743—
Listing of Ingredients in Tobacco
Products) as an alternative submission
tool.’’ is corrected to read ‘‘FDA also
developed paper forms (Form FDA
3741—Registration and Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Form FDA 3742—Listing of Ingredients
in Tobacco Products) as an alternative
submission tool.’’
2. On page 26283, in the table, ‘‘Form
FDA 3742’’ is corrected to read ‘‘Form
FDA 3741’’ and ‘‘Form FDA 3743’’ is
corrected to read ‘‘Form FDA 3742’’.
SUMMARY:
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[FR Doc. 2012–22919 Filed 9–17–12; 8:45 am]
BILLING CODE 4160–01–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration and
Product Listing for Owners and
Operators of Domestic Tobacco
Product Establishments and Listing of
Ingredients in Tobacco Products;
Correction
AGENCY:
Dated: September 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0386]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration and
Product Listing for Owners and
Operators of Domestic Tobacco
Product Establishments and Listing of
Ingredients in Tobacco Products;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of August 3, 2012 (77 FR
46441). The document announced that a
proposed collection of information had
been submitted to the Office of
Management and Budget for review and
clearance under the Paperwork
Reduction Act of 1995. The document
published with incorrect FDA form
numbers. This document corrects those
errors.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2012–18975 appearing on page 46441 in
the Federal Register of Friday, August
3, 2012, the following corrections are
made:
1. On page 46442, in the third
column, in the first full paragraph, the
fifth sentence ‘‘FDA also developed
paper forms (Form FDA 3742—
Registration and Listing for Owners and
Operators of Domestic Tobacco Product
Establishments and Form FDA 3743—
Listing of Ingredients in Tobacco
Products) as an alternative submission
tool.’’ is corrected to read ‘‘FDA also
developed paper forms (Form FDA
3741—Registration and Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Form FDA 3742—Listing of Ingredients
in Tobacco Products) as an alternative
submission tool.’’
SUMMARY:
E:\FR\FM\18SEN1.SGM
18SEN1
]]>Agencies
[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Notices]
[Pages 57567-57568]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23017]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Single Source Cooperative Agreement Award for World Health
Organization
AGENCY: Department of Health and Human Services (HHS), Assistant
Secretary for Preparedness and Response (ASPR).
ACTION: Notification of Single Source Cooperative Agreement Award for
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: $400,000.
Project Period: Sept. 30, 2012 to Sept. 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 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 rely 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 (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.
Single Source 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 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
[[Page 57568]]
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 the development of new
antiviral agents, safer vaccines, and better diagnostics, thus
strengthening our national security.
Additional Information: The agency program contact is Richard J.
Hatchett, MD, who can be contacted by phone at (202) 260-0150 or via
email at Richard.Hatchett@hhs.gov.
Dated: September 12, 2012.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2012-23017 Filed 9-17-12; 8:45 am]
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