Vaccine To Protect Children From Anthrax-Public Engagement Workshop, 34994-34995 [2011-14722]
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Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Notices
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Sandra L. Kusumoto,
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Licensing.
[FR Doc. 2011–14814 Filed 6–14–11; 8:45 am]
BILLING CODE 6730–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Vaccine To Protect Children From
Anthrax—Public Engagement
Workshop
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The National Biodefense
Science Board’s (NBSB) Anthrax
Vaccine (AV) Working Group (WG) will
hold a public engagement workshop on
July 7, 2011, to discuss vaccine to
protect children from anthrax. This
meeting is open to the public and prior
registration is required. The public may
attend in-person or by teleconference.
DATES: The NBSB’s AV WG will hold a
public engagement workshop on July 7,
2011, to discuss vaccine to protect
children from anthrax. The meeting will
be from 9 a.m. to 4 p.m. ET.
ADDRESSES: Washington Plaza Hotel, 10
Thomas Circle Northwest, Washington,
DC. The call-in details will be posted as
they become available on the
Workshop’s July meeting Web page at
https://www.phe.gov/PREPAREDNESS/
LEGAL/BOARDS/NBSB/Pages/
default.aspx.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
E-
mail: nbsb@hhs.gov.
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
Health and Human Services established
the NBSB. 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 on other matters related
SUPPLEMENTARY INFORMATION:
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Fmt 4703
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to public health emergency
preparedness and response.
Background: In a letter dated 27 April
2011, the Assistant Secretary for
Preparedness and Response (ASPR), Dr.
Nicole Lurie asked the NBSB to
consider issues related to the use of
anthrax vaccine adsorbed (AVA),
BioThrax®, for children. AVA is
currently in the Strategic National
Stockpile and licensed for use only by
healthy persons 18 to 65 years of age for
traditional pre-exposure vaccination. It
may be used in a declared emergency
under an Emergency Use Authorization
(EUA) for this same population as postexposure prophylaxis in combination
with licensed antibiotics for prevention
of anthrax disease. However, the
pediatric population is not covered by
the EUA due to lack of safety and
immunological data related to the
vaccine. If there was known exposure of
a population of individuals to anthrax
there would be subsequent decisions
about, for example, deployment of
medical countermeasures (MCMs),
evacuation versus sheltering-in-place,
and the airborne spread of anthrax
outside the city.
Questions about the need for a
vaccine program for populations that
may continue to live in impacted areas
may be raised. Because studies have
been done to show safety and
effectiveness of anthrax vaccine only for
adults, if such an anthrax attack were to
occur in the near future, the only way
to use the existing vaccine to protect
children would be to use an
investigational new drug (IND) clinical
protocol. These factors complicate
operational response and public
messaging.
The NBSB has previously identified
the need to look at other MCMs for
pediatric populations. This Public
Engagement Workshop provides an
opportunity to include the public in the
discussion about vaccines to protect
children from anthrax or treat children
exposed to anthrax. The forum includes
discussion of the types of data and types
of studies that may be needed to show
whether existing FDA-approved
vaccines, could also be used for
children. No decisions or
recommendations will be made at the
Workshop.
Availability of Materials: The meeting
agenda and materials will be posted
prior to the meeting on the Workshop’s
July meeting Web page at https://
www.phe.gov/PREPAREDNESS/LEGAL/
BOARDS/NBSB/Pages/default.aspx.
Procedures for Providing Public Input:
Any member of the public planning to
attend in-person must register in
advance by e-mailing nbsb@hhs.gov
E:\FR\FM\15JNN1.SGM
15JNN1
Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Notices
with ‘‘Vaccine to Protect Children from
Anthrax—Public Engagement
Workshop’’ as the subject line and
provide name, address, and affiliation. If
you need special assistance, such as
sign language interpretation or other
reasonable accommodations, please
include that in your registration e-mail.
A ‘‘listen-only’’ teleconference number
will be provided on the Web site.
Written comments and/or questions
may be submitted in advance or during
the Workshop and will be provided to
the Workshop hosts. There will be two
scheduled public comment periods
during the Workshop. Public comments
will be limited to 2 minutes per person.
Dated: June 8, 2011.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2011–14722 Filed 6–14–11; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day-11–11HJ]
jlentini on DSK4TPTVN1PROD with NOTICES
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 or send
comments to Daniel Holcomb, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS D–74, Atlanta, GA 30333 or
send an e-mail to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is 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. Written comments should
VerDate Mar<15>2010
16:42 Jun 14, 2011
Jkt 223001
be received within 60 days of this
notice.
Proposed Project
Comparing the Effectiveness of
Traditional Evidence-Based Tobacco
Cessation Interventions to Newer and
Innovative Interventions Used by
Comprehensive Cancer Control
Programs—New—Division of Cancer
Prevention and Control, National Center
for Chronic Disease Prevention and
Health Promotion, Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Tobacco use remains the leading
preventable cause of death in the United
States, causing over 443,000 deaths each
year and resulting in an annual cost of
more than $96 billion in direct medical
expenses. The only proven strategy for
reducing the risk of tobacco-related
morbidity and mortality is to never
smoke, or to quit if tobacco use has been
initiated. In 1999, CDC’s Office on
Smoking and Health established the
National Tobacco Control Program
(NTCP) to encourage coordinated,
national efforts to reduce tobaccorelated morbidity and mortality. The
NTCP provides funding and technical
support to Tobacco Control Programs
(TCPs) in all 50 states, the District of
Columbia, eight Tribal support centers,
eight U.S. territories or jurisdictions,
and six national networks. TCPs offer
evidence-based cessation interventions
to increase successful quit attempts.
Tobacco control is also a top priority
for Federally-funded Comprehensive
Cancer Control (CCC) programs.
Currently, 65 organizations are funded
through CDC’s National Comprehensive
Cancer Control Program (NCCCP): All
50 states, the District of Columbia, seven
Tribes/Tribal organizations, and seven
U.S. territories/Pacific Island
Jurisdictions. CCCs work to establish
coalitions, assess the burden of cancer,
and implement state cancer plans that
address interventions from primary
prevention to treatment and
survivorship. The NCCCP is managed by
CDC’s Division of Cancer Prevention
and Control (DCPC).
Evidence-based tobacco cessation
interventions include counseling offered
through telephone quitlines (QLs) as
well as Web-based counseling services.
Although all states currently provide a
telephone QL, only 0.05% to 7.25% of
adult smokers receive tobacco cessation
services via a state QL each year. Mass
media (e.g., television, radio, print) has
been shown to be the most important
and consistent driver of call volume to
QLs in some localities, but is resource
intensive. Two recent studies comparing
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Fmt 4703
Sfmt 4703
34995
the relative effectiveness of telephone
versus Web-based interventions have
begun to clarify the impact of each
intervention but are limited in their
generalizability to current TCP
activities. To date there are no
comprehensive studies that have
examined TCP promotional strategies,
the populations affected by these
strategies, and their effect on QL and
Web-based cessation program usage.
To address this gap in knowledge,
CDC proposes to conduct a new study
of state-based TCPs and their client
populations. The study will consist of
two components: (1) Quitline
promotional activities, and (2) cessation
intervention.
Quitline Promotional Activities. The
overall goal of this study component is
to characterize state-based TCP
promotional activities in terms of type
and level of advertising; impact in
relation to QL call volume; and client
characteristics. This study component is
based on existing sources of information
and entails minimal burden to
respondents. Up to 50 state-based TCPs
will be asked to participate over a 15month period. Responding states will
provide media purchasing information
related to cessation promotional
activities and permission to extract deidentified QL call volume data from the
National Quitline Data Warehouse
(NQDW, OMB No. 0920–0856, exp. 7/
31/2012). CDC’s data collection
contractor will also attempt to obtain
Web traffic data using publicly available
tools.
Cessation Intervention. The overall
goal of this study component is to
describe relationships among mode of
cessation service delivery (telephone vs.
Web); client demographics; and quit
success in the last 30 days. A total of
8,000 respondents aged 18 years (4,000
clients who use QL services and 4,000
clients who use Web-based services)
will be recruited to participate in the
study on a voluntary basis. Regular
access to cessation services will be
provided to individuals who choose not
to participate in this study. Respondents
will be recruited from up to four states
over a period of up to 12 months. The
four participating states must be current
NCCCP grantees, have existing
relationships with their state TCP, have
both telephone and Web-based tobacco
cessation programs, and have a statewide QL registry that conforms to the
North American Quitline Consortium’s
Minimal Data Set (MDS), which
provides the framework for the NQDW
data collection.
Information collection for the
cessation study component will consist
of an intake data using MDS-compliant
E:\FR\FM\15JNN1.SGM
15JNN1
]]>Agencies
[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Pages 34994-34995]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14722]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Vaccine To Protect Children From Anthrax--Public Engagement
Workshop
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Biodefense Science Board's (NBSB) Anthrax Vaccine
(AV) Working Group (WG) will hold a public engagement workshop on July
7, 2011, to discuss vaccine to protect children from anthrax. This
meeting is open to the public and prior registration is required. The
public may attend in-person or by teleconference.
DATES: The NBSB's AV WG will hold a public engagement workshop on July
7, 2011, to discuss vaccine to protect children from anthrax. The
meeting will be from 9 a.m. to 4 p.m. ET.
ADDRESSES: Washington Plaza Hotel, 10 Thomas Circle Northwest,
Washington, DC. The call-in details will be posted as they become
available on the Workshop's July meeting Web page at https://www.phe.gov/PREPAREDNESS/LEGAL/BOARDS/NBSB/Pages/default.aspx.
FOR FURTHER INFORMATION CONTACT: E-mail: nbsb@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 Health and Human
Services established the NBSB. 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
on other matters related to public health emergency preparedness and
response.
Background: In a letter dated 27 April 2011, the Assistant
Secretary for Preparedness and Response (ASPR), Dr. Nicole Lurie asked
the NBSB to consider issues related to the use of anthrax vaccine
adsorbed (AVA), BioThrax[supreg], for children. AVA is currently in the
Strategic National Stockpile and licensed for use only by healthy
persons 18 to 65 years of age for traditional pre-exposure vaccination.
It may be used in a declared emergency under an Emergency Use
Authorization (EUA) for this same population as post-exposure
prophylaxis in combination with licensed antibiotics for prevention of
anthrax disease. However, the pediatric population is not covered by
the EUA due to lack of safety and immunological data related to the
vaccine. If there was known exposure of a population of individuals to
anthrax there would be subsequent decisions about, for example,
deployment of medical countermeasures (MCMs), evacuation versus
sheltering-in-place, and the airborne spread of anthrax outside the
city.
Questions about the need for a vaccine program for populations that
may continue to live in impacted areas may be raised. Because studies
have been done to show safety and effectiveness of anthrax vaccine only
for adults, if such an anthrax attack were to occur in the near future,
the only way to use the existing vaccine to protect children would be
to use an investigational new drug (IND) clinical protocol. These
factors complicate operational response and public messaging.
The NBSB has previously identified the need to look at other MCMs
for pediatric populations. This Public Engagement Workshop provides an
opportunity to include the public in the discussion about vaccines to
protect children from anthrax or treat children exposed to anthrax. The
forum includes discussion of the types of data and types of studies
that may be needed to show whether existing FDA-approved vaccines,
could also be used for children. No decisions or recommendations will
be made at the Workshop.
Availability of Materials: The meeting agenda and materials will be
posted prior to the meeting on the Workshop's July meeting Web page at
https://www.phe.gov/PREPAREDNESS/LEGAL/BOARDS/NBSB/Pages/default.aspx.
Procedures for Providing Public Input: Any member of the public
planning to attend in-person must register in advance by e-mailing
nbsb@hhs.gov
[[Page 34995]]
with ``Vaccine to Protect Children from Anthrax--Public Engagement
Workshop'' as the subject line and provide name, address, and
affiliation. If you need special assistance, such as sign language
interpretation or other reasonable accommodations, please include that
in your registration e-mail. A ``listen-only'' teleconference number
will be provided on the Web site. Written comments and/or questions may
be submitted in advance or during the Workshop and will be provided to
the Workshop hosts. There will be two scheduled public comment periods
during the Workshop. Public comments will be limited to 2 minutes per
person.
Dated: June 8, 2011.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2011-14722 Filed 6-14-11; 8:45 am]
BILLING CODE 4150-37-P
