Solicitation of Written Comments on Draft Centers for Disease Control and Prevention's Immunization Safety Office Scientific Agenda, 107-108 [E8-31196]
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Federal Register / Vol. 74, No. 1 / Friday, January 2, 2009 / Notices
Published 12/19/2008: Correction to
Title and Comment Period.
Dated: December 29, 2008.
Robert W. Hargrove,
Director, NEPA Compliance Division, Office
of Federal Activities.
[FR Doc. E8–31218 Filed 12–31–08; 8:45 am]
BILLING CODE 6560–50–P
Irvine, California; to acquire up to 18
percent of Heritage Bank, National
Association, New York, New York.
Board of Governors of the Federal Reserve
System, December 29, 2008.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. E8–31199 Filed 12–31–08; 8:45 am]
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Solicitation of Written Comments on
Draft Centers for Disease Control and
Prevention’s Immunization Safety
Office Scientific Agenda
GENERAL SERVICES
ADMINISTRATION
The companies listed in this notice
have applied to the Board for approval,
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and regulations to become a bank
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including the companies listed below.
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L.P., CCFW, Inc., and SCJ, Inc., all of
Dated: December 29, 2008.
Russell H. Pentz,
Assistant Deputy Associate Administrator,
Office of Travel, Transportation, and Asset
Management.
[FR Doc. E8–31231 Filed 12–31–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 6210–01–S
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AGENCY: Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
SUMMARY: The National Vaccine
Program Office (NVPO) is soliciting
public comment on the Centers for
Disease Control and Prevention’s
Immunization Safety Office (ISO) draft
Scientific Agenda related to scientific
research questions in vaccine safety.
DATES: Comments on the draft ISO
Scientific Agenda should be received no
later than 5 p.m. on February 2, 2009.
ADDRESSES: Electronic responses are
preferred and may be addressed to
vaccinsafetyRFI@hhs.gov. Written
responses should be addressed to
National Vaccine Program Office, U.S.
Department of Health and Human
Services, 200 Independence Avenue,
SW., Room 443–H, Washington, DC
20201, Attention: Vaccine Safety RFI.
FOR FURTHER INFORMATION CONTACT: Ms.
Kirsten Vannice, National Vaccine
Program Office, Department of Health
and Human Services, Hubert H.
Humphrey Building, 200 Independence
Avenue, SW., Room 443–H,
Washington, DC 20201; telephone (202)
690–5566; fax 202–260–1165; e-mail
vaccinesafetyRFI@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Ensuring the optimal safety of
vaccines and immunizations is
important to everyone. NVPO is located
within the Office of Public Health and
Science within the Office of the
Secretary, Department of Health and
Human Services (HHS), and has
responsibility for coordinating and
ensuring collaboration among the many
Federal agencies involved in vaccine
and immunization activities. NVAC is a
statutory Federal advisory committee
that provides advice and makes
recommendations to the Director of the
National Vaccine Program on matters
related to the program.
E:\FR\FM\02JAN1.SGM
02JAN1
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108
Federal Register / Vol. 74, No. 1 / Friday, January 2, 2009 / Notices
Vaccine safety research is done from
the time vaccine development begins
through when it is licensed and used
routinely. Within HHS, vaccine and
vaccine safety research during the
development process is supported
primarily by the National Institutes of
Health. The Food and Drug
Administration then carefully reviews
safety and effectiveness information in
deciding whether a vaccine should be
licensed. After licensure, when a
vaccine is used in children, adolescents
or adults, its safety is monitored and
further scientific studies are done to
assure that the vaccine is safe, to
evaluate potential safety problems, or to
identify ways that the vaccine can be
used more safely.
The Center for Disease Control and
Prevention’s (CDC) Immunization Safety
Office (ISO) has significant
responsibility for monitoring and
studying the safety of vaccines after they
are licensed and used in the United
States (https://www.cdc.gov/
vaccinesafety). ISO has drafted a
scientific agenda that identifies vaccine
safety issues to consider for scientific
study over the next five years, in
addition to any new questions that may
arise. Since not all questions and issues
can be addressed at once, setting
priorities is important. The draft ISO
Scientific Agenda can be found at:
https://www.cdc.gov/vaccinesafety/
00_pdf/draft_agenda_
recommendations_080404.pdf and the
addendum at https://www.cdc.gov/
vaccinesafety/00_pdf/
draft_recommendations_add_080410
.pdf.
ISO has requested a review of the
draft Scientific Agenda by the National
Vaccine Advisory Committee (NVAC).
The NVAC review of the draft ISO
Scientific Agenda will include
providing recommendations on the
agenda contents and on priorities for
scientific research either done or funded
by ISO. Public and stakeholder input
will be important to the development of
the NVAC recommendations, along with
the expertise of the NVAC and NVAC
Vaccine Safety Working Group
members. Public and stakeholder input
is being requested by written comment
in response to this RFI; at community
meetings taking place in Ashland, OR,
Birmingham, AL, and Indianapolis, IN;
at a meeting of stakeholders; and at a
meeting of the NVAC Vaccine Safety
Working Group (for more information,
see https://www.hhs.gov/nvpo/nvac/
PublicEngagement.html).
Through this RFI, HHS is seeking
comments from everyone, including
stakeholders and the broad public.
Comments received will be available for
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public viewing and will be presented in
an open meeting on February 4, 2009, to
the NVAC Vaccine Safety Working
Group.
II. Information Request
NVPO, on behalf of the NVAC
Vaccine Safety Working Group requests
input in three broad areas: (1) Concerns
about vaccines and immunization
safety, (2) comments on what values,
considerations, or factors are most
important to consider in prioritizing
scientific research, and (3) specific
comments on the draft ISO Scientific
Agenda. Responders may address one or
all of the topics below.
(1) Concerns about vaccines and
immunization safety: What are your
primary concerns about the safety of
vaccines and immunization? Why are
those concerns most important to you?
If interested, please share any personal
experience that may further explain
your concerns and their importance.
[Provide up to 3 pages for an answer to
this question]
(2) Comments on what values or
factors are most important to consider
in prioritizing scientific research: What
values, considerations, or factors are
most important to you in deciding what
vaccine and immunization safety
research should be conducted first?
Why are these values, considerations,
and factors most important to you?
Examples of values or factors that you
may consider include, but are not
limited to, the frequency, severity, or
duration of an event; the age, number of
people, or vulnerability of persons
exposed to a vaccine; the amount of
scientific or public concern; and
whether or not a vaccine is required for
child-care or school entry or as a
condition for employment. [Provide up
to 3 pages for an answer to this
question]
(3) Specific comments on the ISO
draft scientific agenda: The draft CDC
ISO Scientific Agenda can be viewed
and downloaded from the CDC Web site
(internet address is provided in the
Background section, above).
a. Please provide any general
comments on the draft ISO Scientific
Agenda.
b. The following questions relate to
the 30 items identified as potential
5-year research needs (see page 27 of
draft ISO Scientific Agenda for a
condensed list):
i. What scientific issues should be
included in the draft ISO Scientific
Agenda that are not there now, or what
issues that are currently included
should be removed? Why should these
issues be added or deleted?
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ii. What issues in the draft ISO
Scientific Agenda are most important to
you and should be made a priority to
study and what issues are least
important to you? Why are they the
highest or lowest priorities?
[Provide up to 3 pages for an answer to
this question]
III. Potential Responders
HHS invites input from a broad range
of individuals and organizations that
have interests in vaccines and vaccine
safety. Some examples of these
organizations include but are not
limited to the following:
—General public;
—Advocacy groups and public interest
organizations;
—State and local governments;
—State and local public health
departments;
—Vaccine manufacturing industry,
distributors and other businesses;
—Health care professional societies and
organizations.
When responding, please self-identify
with any of the above or other categories
(include all that apply) and your name.
Anonymous submissions will not have
their comments posted.
The submission of written materials
in response to the RFI should not
exceed 9 pages (3 pages for each of the
three broad topics), not including
appendices and supplemental
documents. Responders may submit
other forms of electronic materials to
demonstrate or exhibit concepts of their
written responses. Any information you
submit will be made public.
Consequently, do not send proprietary,
commercial, financial, business
confidential, trade secret, or personal
information that you do not wish to be
made public.
Public Access: Responses to this RFI
will be available to the public on the
NVAC Web site at https://www.hhs.gov/
nvpo/nvac/PublicEngagement/
RFIresponses.html. You may access
public comments received from this RFI
by going to the above Web site.
Dated: December 22, 2008.
Raymond A. Strikas,
Acting Director, National Vaccine Program
Office, U.S. Department of Health and Human
Services.
[FR Doc. E8–31196 Filed 12–31–08; 8:45 am]
BILLING CODE 4150–44–P
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]]>Agencies
[Federal Register Volume 74, Number 1 (Friday, January 2, 2009)]
[Notices]
[Pages 107-108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31196]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Written Comments on Draft Centers for Disease
Control and Prevention's Immunization Safety Office Scientific Agenda
AGENCY: Department of Health and Human Services, Office of the
Secretary.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Vaccine Program Office (NVPO) is soliciting
public comment on the Centers for Disease Control and Prevention's
Immunization Safety Office (ISO) draft Scientific Agenda related to
scientific research questions in vaccine safety.
DATES: Comments on the draft ISO Scientific Agenda should be received
no later than 5 p.m. on February 2, 2009.
ADDRESSES: Electronic responses are preferred and may be addressed to
vaccinsafetyRFI@hhs.gov. Written responses should be addressed to
National Vaccine Program Office, U.S. Department of Health and Human
Services, 200 Independence Avenue, SW., Room 443-H, Washington, DC
20201, Attention: Vaccine Safety RFI.
FOR FURTHER INFORMATION CONTACT: Ms. Kirsten Vannice, National Vaccine
Program Office, Department of Health and Human Services, Hubert H.
Humphrey Building, 200 Independence Avenue, SW., Room 443-H,
Washington, DC 20201; telephone (202) 690-5566; fax 202-260-1165; e-
mail vaccinesafetyRFI@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Ensuring the optimal safety of vaccines and immunizations is
important to everyone. NVPO is located within the Office of Public
Health and Science within the Office of the Secretary, Department of
Health and Human Services (HHS), and has responsibility for
coordinating and ensuring collaboration among the many Federal agencies
involved in vaccine and immunization activities. NVAC is a statutory
Federal advisory committee that provides advice and makes
recommendations to the Director of the National Vaccine Program on
matters related to the program.
[[Page 108]]
Vaccine safety research is done from the time vaccine development
begins through when it is licensed and used routinely. Within HHS,
vaccine and vaccine safety research during the development process is
supported primarily by the National Institutes of Health. The Food and
Drug Administration then carefully reviews safety and effectiveness
information in deciding whether a vaccine should be licensed. After
licensure, when a vaccine is used in children, adolescents or adults,
its safety is monitored and further scientific studies are done to
assure that the vaccine is safe, to evaluate potential safety problems,
or to identify ways that the vaccine can be used more safely.
The Center for Disease Control and Prevention's (CDC) Immunization
Safety Office (ISO) has significant responsibility for monitoring and
studying the safety of vaccines after they are licensed and used in the
United States (https://www.cdc.gov/vaccinesafety). ISO has drafted a
scientific agenda that identifies vaccine safety issues to consider for
scientific study over the next five years, in addition to any new
questions that may arise. Since not all questions and issues can be
addressed at once, setting priorities is important. The draft ISO
Scientific Agenda can be found at: https://www.cdc.gov/vaccinesafety/
00_pdf/draft_agenda_recommendations_080404.pdf and the addendum at
https://www.cdc.gov/vaccinesafety/00_pdf/draft_recommendations_add_
080410.pdf.
ISO has requested a review of the draft Scientific Agenda by the
National Vaccine Advisory Committee (NVAC).
The NVAC review of the draft ISO Scientific Agenda will include
providing recommendations on the agenda contents and on priorities for
scientific research either done or funded by ISO. Public and
stakeholder input will be important to the development of the NVAC
recommendations, along with the expertise of the NVAC and NVAC Vaccine
Safety Working Group members. Public and stakeholder input is being
requested by written comment in response to this RFI; at community
meetings taking place in Ashland, OR, Birmingham, AL, and Indianapolis,
IN; at a meeting of stakeholders; and at a meeting of the NVAC Vaccine
Safety Working Group (for more information, see https://www.hhs.gov/
nvpo/nvac/PublicEngagement.html).
Through this RFI, HHS is seeking comments from everyone, including
stakeholders and the broad public. Comments received will be available
for public viewing and will be presented in an open meeting on February
4, 2009, to the NVAC Vaccine Safety Working Group.
II. Information Request
NVPO, on behalf of the NVAC Vaccine Safety Working Group requests
input in three broad areas: (1) Concerns about vaccines and
immunization safety, (2) comments on what values, considerations, or
factors are most important to consider in prioritizing scientific
research, and (3) specific comments on the draft ISO Scientific Agenda.
Responders may address one or all of the topics below.
(1) Concerns about vaccines and immunization safety: What are your
primary concerns about the safety of vaccines and immunization? Why are
those concerns most important to you? If interested, please share any
personal experience that may further explain your concerns and their
importance. [Provide up to 3 pages for an answer to this question]
(2) Comments on what values or factors are most important to
consider in prioritizing scientific research: What values,
considerations, or factors are most important to you in deciding what
vaccine and immunization safety research should be conducted first? Why
are these values, considerations, and factors most important to you?
Examples of values or factors that you may consider include, but are
not limited to, the frequency, severity, or duration of an event; the
age, number of people, or vulnerability of persons exposed to a
vaccine; the amount of scientific or public concern; and whether or not
a vaccine is required for child-care or school entry or as a condition
for employment. [Provide up to 3 pages for an answer to this question]
(3) Specific comments on the ISO draft scientific agenda: The draft
CDC ISO Scientific Agenda can be viewed and downloaded from the CDC Web
site (internet address is provided in the Background section, above).
a. Please provide any general comments on the draft ISO Scientific
Agenda.
b. The following questions relate to the 30 items identified as
potential 5-year research needs (see page 27 of draft ISO Scientific
Agenda for a condensed list):
i. What scientific issues should be included in the draft ISO
Scientific Agenda that are not there now, or what issues that are
currently included should be removed? Why should these issues be added
or deleted?
ii. What issues in the draft ISO Scientific Agenda are most
important to you and should be made a priority to study and what issues
are least important to you? Why are they the highest or lowest
priorities?
[Provide up to 3 pages for an answer to this question]
III. Potential Responders
HHS invites input from a broad range of individuals and
organizations that have interests in vaccines and vaccine safety. Some
examples of these organizations include but are not limited to the
following:
--General public;
--Advocacy groups and public interest organizations;
--State and local governments;
--State and local public health departments;
--Vaccine manufacturing industry, distributors and other businesses;
--Health care professional societies and organizations.
When responding, please self-identify with any of the above or
other categories (include all that apply) and your name. Anonymous
submissions will not have their comments posted.
The submission of written materials in response to the RFI should
not exceed 9 pages (3 pages for each of the three broad topics), not
including appendices and supplemental documents. Responders may submit
other forms of electronic materials to demonstrate or exhibit concepts
of their written responses. Any information you submit will be made
public. Consequently, do not send proprietary, commercial, financial,
business confidential, trade secret, or personal information that you
do not wish to be made public.
Public Access: Responses to this RFI will be available to the
public on the NVAC Web site at https://www.hhs.gov/nvpo/nvac/
PublicEngagement/RFIresponses.html. You may access public comments
received from this RFI by going to the above Web site.
Dated: December 22, 2008.
Raymond A. Strikas,
Acting Director, National Vaccine Program Office, U.S. Department of
Health and Human Services.
[FR Doc. E8-31196 Filed 12-31-08; 8:45 am]
BILLING CODE 4150-44-P
