Single Source Cooperative Agreement Award for the World Health Organization (WHO) To Continue Development of Sustainable Influenza Vaccine Production, 48691-48692 [2010-19861]
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Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
sroberts on DSKD5P82C1PROD with NOTICES
The Interagency Working Group on
Youth Programs is comprised of staff
from twelve Federal agencies that
support programs and services that
focus on youth: The U.S. Department of
Agriculture; U.S. Department of
Commerce; U.S. Department of Defense;
U.S. Department of Education; U.S.
Department of Health and Human
Services (Chair); U.S. Department of
Housing and Urban Development; U.S.
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Department of Labor; U.S. Department
of the Interior; U.S. Department of
Transportation; Corporation for National
and Community Service; and Office of
National Drug Control Policy.
The Working Group seeks to promote
achievement of positive results for atrisk youth through the following
activities:
• Promoting enhanced collaboration
at the Federal, state, and local levels,
including with faith-based and other
community organizations, as well as
among families, schools and
communities, in order to leverage
existing resources and improve
outcomes;
• Disseminating information about
critical resources, including evidencebased programs, to assist interested
citizens and decision-makers,
particularly at the community level, to
plan, implement, and participate in
effective strategies for at-risk youth;
• Developing an overarching strategic
plan for federal youth policy, as well as
recommendations for improving the
coordination, effectiveness and
efficiency of youth programs, using
input from community stakeholders,
including youth; and
• Producing a Federal Web site,
FindYouthInfo.gov, to promote effective
community-based efforts to reduce the
factors that put youth at risk and to
provide high-quality services to at-risk
youth.
II. Registration, Security, Building, and
Parking Guidelines
For security purposes, members of the
public who wish to attend the meeting
must pre-register on-line at https://
www.findyouthinfo.gov no later than
(seven days before the meeting). Should
problems arise with Web registration,
call the help desk at 1–877–231–7843 or
send a request to register for the meeting
to FindYouthInfo@air.org. To register,
complete the online registration form,
which will ask for your name, title,
organization or other affiliation, full
address and phone, fax, and e-mail
information or e-mail this information
to FindYouthInfo@air.org. Additional
identification documents may be
required.
VerDate Mar<15>2010
16:52 Aug 10, 2010
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The meetings are held in a Federal
government building; therefore, Federal
security measures are applicable. In
planning your arrival time, we
recommend allowing additional time to
clear security. Space is limited. In order
to gain access to the building and
grounds, participants must bring
government-issued photo identification
as well as their pre-registration
confirmation.
Authority: Division F, Pub. L. 111–8; E.O.
13459, 73 FR 8003, February 12, 2008
Dated: August 3, 2010.
Sherry Glied,
Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2010–19857 Filed 8–10–10; 8:45 am]
BILLING CODE 4154–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Single Source Cooperative Agreement
Award for the World Health
Organization (WHO) To Continue
Development of Sustainable Influenza
Vaccine Production
Department of Health and
Human Services, Assistant Secretary for
Preparedness and Response, Biomedical
Advanced Research Development
Authority
ACTION: Notice.
AGENCY:
Notification of Single Source
Cooperative Agreement Award for the
World Health Organization (WHO) To
Continue Development of Sustainable
Influenza Vaccine Production Capacity
in Under-Resourced Nations CFDA#:
93.360.
SUMMARY:
Statutory Authority: Section 319L of the
Public Health Service (PHS) Act, 42 U.S.C.
247d–7e as amended by Title IV of the
Pandemic and All-Hazards Preparedness Act
(PAHPA), Pub. L. 109–417; and the
Consolidated Appropriations Act, 2010, Pub.
L. 111–117.
Amount of Single Source Award:
$6,400,000.
Project Period: September 30, 2010
through September 29, 2013.
In FY 2010, BARDA plans to provide
a Single Source Continuation Award to
the World Health Organization to
support the International Vaccine
Production Capacity-Building Program.
BARDA currently funds the
development of vaccine manufacturing
capacity in ten developing and
emerging-economy countries worldwide
via a cooperative agreement with the
World Health Organization (WHO). The
WHO has proven to be a key partner and
integral to the success of the program,
which has been in existence since 2006.
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48691
Continuing the partnership with the
WHO will prove critical to the long-term
viability of this program while
bolstering the influenza vaccine
manufacturing capabilities of resource
poor nations and global pandemic
preparedness overall.
Single Source Justification: The
International Vaccine Capacity Building
Program, supported by the Department
of Health and Human Services,
Assistant Secretary for Preparedness
and Response, Biomedical Advanced
Research and Development Authority
was developed and has been operational
since 2006. In light of the threat of an
influenza pandemic it was originally
designed with the goals of bolstering
both international and domestic
pandemic preparedness and response.
The fundamental approach in achieving
these goals has been through the
development of the influenza vaccine
production capabilities of under
resourced nations in the hopes that they
will ultimately be able to produce
vaccines to protect the local, regional,
and international public health. The
program is supported by a collaborative
of U.S. Government agencies,
international organizations, foreign
ministries and/or other foreign
institutions dedicated to achieving these
goals.
The WHO is the only global
organization with the experience and
scientific standing to accomplish the
program goals. It is the recognized
world health authority within the
United Nations system. Similarly, the
liaison and support functions that the
WHO plays within the international
vaccine production capacity building
program cannot be duplicated or
replicated. Through standing
consultation and dialog with its
members states on all aspects of public
health, WHO is the only partner able to
ensure synchronization of building of
production capacity in developing
countries for influenza vaccine with
other pandemic preparedness activities
and with increase of demand for
seasonal influenza immunization.
The WHO’s strong collaborative
relationships with foreign governments,
programmatic support, and familiarity
with international vaccine production
institutions have been and will be
critical to the future viability of this
program. Over the history of the
International Vaccine Production
Capacity Building program, the WHO
has provided unique and invaluable
support to the project. Similarly, the
WHO has also independently funded
other nations/institutions working to
strengthen their influenza vaccine
production capacity; also demonstrating
E:\FR\FM\11AUN1.SGM
11AUN1
48692
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
their commitment to the success of this
program. The WHO represents a key
stakeholder in the implementation of
the program; providing unique
functions, technical and scientific
expertise, and capabilities that no other
organization in the world has.
Additional Information: The agency
program contact is Dr. Michael Perdue,
whom can be contacted at (202) 260–
0966 or Michael.Perdue@hhs.gov.
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Dated: August 3, 2010.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response, U.S. Department of Health and
Human Services.
Proposed Project: The Stem Cell
Therapeutic Outcomes Database (OMB
No. 0915–0310)—Extension
[FR Doc. 2010–19861 Filed 8–10–10; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
The Stem Cell Therapeutic and
Research Act of 2005 provides for the
collection and maintenance of human
cord blood stem cells for the treatment
of patients and research. The Health
Resources and Services
Administration’s (HRSA) Healthcare
Systems Bureau (HSB) has established
the Stem Cell Therapeutic Outcomes
Database. Operation of this database
necessitates certain recordkeeping and
reporting requirements in order to
perform the functions related to
hematopoietic stem cell transplantation
under contract to the Department of
Health and Human Services (HHS). The
Act requires the Secretary of HHS to
contract for the establishment and
maintenance of information related to
patients who have received stem cell
Number of
respondents
Form
Responses per
respondent
Baseline Pre-TED (Transplant Essential Data) ...............
Product Forms (includes Infusion, HLA, and Infectious
Disease Marker inserts) ...............................................
100-Day Post-TED ...........................................................
6-Month Post-TED ...........................................................
12-Month Post-TED .........................................................
Annual Post-TED .............................................................
200
30
200
200
200
200
200
Total ..........................................................................
200
sroberts on DSKD5P82C1PROD with NOTICES
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: August 5, 2010.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2010–19752 Filed 8–10–10; 8:45 am]
20
30
25
23.5
64
4,000
6,000
5,000
4,700
12,800
1.5
0.85
1.00
1.00
1.00
6,000
5,100
5,000
4,700
12,800
..........................
38,500
..........................
38,700
[Docket No. FDA–2010–N–0411]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guide to Minimize
Microbial Food Safety Hazards of
Fresh-Cut Fruits and Vegetables
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
16:52 Aug 10, 2010
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Total burden
hours
5,100
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Hours per
Response
0.85
Food and Drug Administration
ACTION:
Total
responses
6,000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
therapeutic products and to do so using
a standardized, electronic format. Data
are collected from transplant centers in
a manner similar to the data collection
activities conducted by the Center for
International Blood and Marrow
Transplant Research (CIBMTR) and are
used for ongoing analysis of transplant
outcomes. HRSA uses the information
in order to carry out its statutory
responsibilities. Information is needed
to monitor the clinical status of
transplantation, and to provide the
Secretary with an annual report of
transplant center-specific survival data.
The burden table for the year 2011
shows there will be approximately
12,800 annual follow-up assessments
due for the Blood Stem Cell
Transplantation Program’s Stem Cell
Therapeutic Outcomes Database. The
2007 30-Day Federal Register notice
included total burden hours of 32,040
and 225 respondents. The burden table
below includes 38,700 total burden
hours and 200 respondents. The
increase in burden is due to an increase
in the annual number of transplants.
The number of respondents has
decreased due to some centers no longer
performing unrelated stem cell
transplants and some centers are no
longer in business.
The estimate of burden is as follows:
Sfmt 4703
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions in
the guidance document entitled
‘‘Guidance for Industry: Guide to
Minimize Microbial Food Safety
Hazards of Fresh-Cut Fruits and
Vegetables.’’
DATES: Submit either electronic or
written comments on the collection of
information by October 12, 2010.
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48691-48692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19861]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Single Source Cooperative Agreement Award for the World Health
Organization (WHO) To Continue Development of Sustainable Influenza
Vaccine Production
AGENCY: Department of Health and Human Services, Assistant Secretary
for Preparedness and Response, Biomedical Advanced Research Development
Authority
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notification of Single Source Cooperative Agreement Award for
the World Health Organization (WHO) To Continue Development of
Sustainable Influenza Vaccine Production Capacity in Under-Resourced
Nations CFDA: 93.360.
Statutory Authority: Section 319L of the Public Health Service
(PHS) Act, 42 U.S.C. 247d-7e as amended by Title IV of the Pandemic
and All-Hazards Preparedness Act (PAHPA), Pub. L. 109-417; and the
Consolidated Appropriations Act, 2010, Pub. L. 111-117.
Amount of Single Source Award: $6,400,000.
Project Period: September 30, 2010 through September 29, 2013.
In FY 2010, BARDA plans to provide a Single Source Continuation
Award to the World Health Organization to support the International
Vaccine Production Capacity-Building Program. BARDA currently funds the
development of vaccine manufacturing capacity in ten developing and
emerging-economy countries worldwide via a cooperative agreement with
the World Health Organization (WHO). The WHO has proven to be a key
partner and integral to the success of the program, which has been in
existence since 2006. Continuing the partnership with the WHO will
prove critical to the long-term viability of this program while
bolstering the influenza vaccine manufacturing capabilities of resource
poor nations and global pandemic preparedness overall.
Single Source Justification: The International Vaccine Capacity
Building Program, supported by the Department of Health and Human
Services, Assistant Secretary for Preparedness and Response, Biomedical
Advanced Research and Development Authority was developed and has been
operational since 2006. In light of the threat of an influenza pandemic
it was originally designed with the goals of bolstering both
international and domestic pandemic preparedness and response. The
fundamental approach in achieving these goals has been through the
development of the influenza vaccine production capabilities of under
resourced nations in the hopes that they will ultimately be able to
produce vaccines to protect the local, regional, and international
public health. The program is supported by a collaborative of U.S.
Government agencies, international organizations, foreign ministries
and/or other foreign institutions dedicated to achieving these goals.
The WHO is the only global organization with the experience and
scientific standing to accomplish the program goals. It is the
recognized world health authority within the United Nations system.
Similarly, the liaison and support functions that the WHO plays within
the international vaccine production capacity building program cannot
be duplicated or replicated. Through standing consultation and dialog
with its members states on all aspects of public health, WHO is the
only partner able to ensure synchronization of building of production
capacity in developing countries for influenza vaccine with other
pandemic preparedness activities and with increase of demand for
seasonal influenza immunization.
The WHO's strong collaborative relationships with foreign
governments, programmatic support, and familiarity with international
vaccine production institutions have been and will be critical to the
future viability of this program. Over the history of the International
Vaccine Production Capacity Building program, the WHO has provided
unique and invaluable support to the project. Similarly, the WHO has
also independently funded other nations/institutions working to
strengthen their influenza vaccine production capacity; also
demonstrating
[[Page 48692]]
their commitment to the success of this program. The WHO represents a
key stakeholder in the implementation of the program; providing unique
functions, technical and scientific expertise, and capabilities that no
other organization in the world has.
Additional Information: The agency program contact is Dr. Michael
Perdue, whom can be contacted at (202) 260-0966 or
Michael.Perdue@hhs.gov.
Dated: August 3, 2010.
Nicole Lurie,
Assistant Secretary for Preparedness and Response, U.S. Department of
Health and Human Services.
[FR Doc. 2010-19861 Filed 8-10-10; 8:45 am]
BILLING CODE 4150-37-P
