Solicitation of Nominations for Membership on the National Vaccine Advisory Committee, 79132-79133 [E8-30614]
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79132
Federal Register / Vol. 73, No. 248 / Wednesday, December 24, 2008 / Notices
Dated: December 17, 2008.
David A. Drabkin,
Deputy Chief Acquisition Officer, Office of
the Chief Acquisition Officer, General
Services Administration.
[FR Doc. E8–30557 Filed 12–23–08; 8:45 am]
BILLING CODE 6820–EP–S
GENERAL SERVICES
ADMINISTRATION
AGENCY: Office of Small Business
Utilization, GSA.
ACTION: Notice.
mstockstill on PROD1PC66 with NOTICES
SUMMARY: The General Services
Administration (GSA) is announcing a
public meeting of the GSA Small
Business Advisory Committee,
Subcommittee on Service-Disabled
Veteran-Owned Small Businesses (the
Subcommittee).
DATES: The meeting will take place
January 13, 2009. The meeting will
begin at 1 p.m. and conclude no later
than 4 p.m. that day. The Subcommittee
will accept oral public comments at this
meeting and has reserved a total of
thirty minutes for this purpose.
Members of the public wishing to
reserve speaking time must contact the
DFO in writing at: sbac@gsa.gov or by
fax at (202) 501–2590, no later than one
week prior to the meeting. Individuals
interested in attending the meeting
should contact the DFO prior to the
meeting date to expedite security
procedures for building admittance.
ADDRESSES: GSA Building, 1800 F
Street, NW., Washington, DC 20405
FOR FURTHER INFORMATION CONTACT:
Lucy Jenkins or Aaron Collmann, Room
6029, GSA Building, 1800 F Street, NW.,
Washington, DC 20405 (202) 501–1021
or e-mail at sbac@gsa.gov.
SUPPLEMENTARY INFORMATION: This
notice is published in accordance with
the provisions of the Federal Advisory
Committee Act (FACA) (Pub. L. 92–
463). The purpose of this meeting is to
generate topics for future discussion and
to hear from interested members of the
public on proposals to improve GSA’s
SDVOSB contracting performance.
Topics for this meeting will include
but are not limited to welcoming the
members to the subcommittee, the
members annual ethics briefing and
discussion of GSA’s Veteran Outreach
Program (21 Gun Salute) and
18:45 Dec 23, 2008
Dated: December 18, 2008.
Michael J. Rigas,
Associate Administrator, Office of Small
Business Utilization, General Services
Administration.
[FR Doc. E8–30634 Filed 12–23–08; 8:45 am]
BILLING CODE 6820–34–P
Office of Small Business Utilization;
Small Business Advisory Committee;
Notification of a Public Meeting of the
Small Business Advisory Committee,
Subcommittee on Service-Disabled
Veteran-Owned Small Businesses
VerDate Aug<31>2005
improvements to the program.
Information on the full Small Business
Advisory Committee can be found
online at https://www.gsa.gov/sbac.
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Membership on the National Vaccine
Advisory Committee
AGENCY: Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science.
ACTION: Notice.
AUTHORITY: 42 U.S.C. 300aa–5, Section
2105 of the Public Health Service (PHS) Act,
as amended. The Committee is governed by
the provisions of Public Law 92–463, as
amended (5 U.S.C. Appendix 2), which sets
forth standards for the formation and use of
advisory committees.
SUMMARY: The National Vaccine
Program Office (NVPO), a program
office within the Office of Public Health
and Science, Department of Health and
Human Services (HHS), is soliciting
nominations of qualified candidates to
be considered for appointment as
members to the National Vaccine
Advisory Committee (NVAC). The
activities of this Committee are
governed by the Federal Advisory
Committee Act (FACA). Management
support for the activities of this
Committee is the responsibility of the
NVPO.
Consistent with the National Vaccine
Plan, the Committee advises and makes
recommendations to the Assistant
Secretary for Health in his capacity as
the Director of the National Vaccine
Program, on matters related to the
Program’s responsibilities. Specifically,
the Committee studies and recommends
ways to encourage the availability of an
adequate supply of safe and effective
vaccination products in the United
States; recommends research priorities
and other measures to enhance the
safety and efficacy of vaccines. The
Committee also advises the Assistant
Secretary for Health in the
implementation of Sections 2102 and
2103 of the PHS Act; and identifies
annually the most important areas of
government and non-government
cooperation that should be considered
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in implementing Sections 2102 and
2103 of the PHS Act.
DATES: All nominations for membership
on the Committee must be received no
later than 5 p.m. EDT on February 2,
2009, at the address listed below.
ADDRESSES: All nominations should be
mailed or delivered to: Bruce Gellin,
M.D., M.P.H., Executive Secretary,
NVAC, Office of Public Health and
Science, Department of Health and
Human Services, 200 Independence
Avenue, SW., Room 443–H, Hubert H.
Humphrey Building; Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT: Ms.
Andrea Krull, Public Health Advisor,
National Vaccine Program Office,
Department of Health and Human
Services, 200 Independence Avenue,
SW., Room 443–H, Hubert H. Humphrey
Building, Washington, DC 20201; (202)
690–5566; nvpo@hhs.gov.
A copy of the Committee charter
which includes the Committee’s
structure and functions as well as a list
of the current membership can be
obtained by contacting Ms. Krull or by
accessing the NVAC Web site at: https://
www.hhs.gov/nvpo/nvac.
SUPPLEMENTARY INFORMATION: Committee
Function, Qualifications, and
Information Required: As part of an
ongoing effort to enhance deliberations
and discussions with the public on
vaccine and immunization policy,
nominations are being sought for
interested individuals to serve on the
Committee. Individuals selected for
appointment to the Committee will
serve as voting members. The NVAC
consists of 17 voting members. The
Committee is composed of 15 public
members, including the Chair, and two
representative members. Public
members shall be selected from
individuals who are engaged in vaccine
research or the manufacture of vaccines,
or who are physicians, members of
parent organizations concerned with
immunizations, representatives of state
or local health agencies or public health
organizations. Representative members
shall be selected from the vaccine
manufacturing industry who are
engaged in vaccine research or the
manufacture of vaccines. Individuals
selected for appointment to the
Committee can be invited to serve terms
of up to four years.
All NVAC members are authorized to
receive the prescribed per diem
allowance and reimbursement for travel
expenses that are incurred to attend
meetings and conduct authorized
Committee-related business, in
accordance with Standard Government
Travel Regulations. Individuals who are
E:\FR\FM\24DEN1.SGM
24DEN1
Federal Register / Vol. 73, No. 248 / Wednesday, December 24, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
appointed to serve as public members
are authorized also to receive
honorarium for attending Committee
meetings and to carry out other
authorized Committee-related business.
Individuals who are appointed to serve
as representative members for a
particular interest group or industry are
not authorized to receive honorarium
for the performance of these duties.
This announcement is to solicit
nominations of qualified candidates to
fill positions on the NVAC that are
scheduled to be vacated in the public
member category. The positions are
scheduled to be vacated on March 31,
2009.
Nominations
In accordance with the charter,
persons nominated for appointment as
members of the NVAC should be among
authorities knowledgeable in areas
related to vaccine safety, vaccine
effectiveness, and vaccine supply.
Nominations should be typewritten. The
following information should be
included in the package of material
submitted for each individual being
nominated for consideration: (1) A letter
of nomination that clearly states the
name and affiliation of the nominee, the
basis for the nomination (i.e., specific
attributes which qualify the nominee for
service in this capacity); (2) a statement
from the nominee, bearing an original
signature, that, if appointed, he or she
is willing to serve as a member of the
Committee; (3) the nominator’s name,
address and daytime telephone number,
and the home and/or work address,
telephone number, and email address of
the individual being nominated; and (4)
a current copy of the nominee’s
curriculum vitae.
Individuals can nominate themselves
for consideration of appointment to the
Committee. All nominations must
include the required information.
Incomplete nominations will not be
processed for consideration. The letter
from the nominator and certification of
the nominated individual must bear
original signatures; reproduced copies
of these signatures are not acceptable.
Applications cannot be submitted by
facsimile. The names of Federal
employees should not be nominated for
consideration of appointment to this
Committee.
The Department makes every effort to
ensure that the membership of HHS
Federal advisory committees is fairly
balanced in terms of points of view
represented and the committee’s
function. Every effort is made that a
broad representation of geographic
areas, gender, ethnic and minority
groups, and the disabled are given
VerDate Aug<31>2005
18:45 Dec 23, 2008
Jkt 217001
consideration for membership on HHS
Federal advisory committees.
Appointment to this committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status.
The Standards of Ethical Conduct for
Employees of the Executive Branch are
applicable to individuals who are
appointed as public members of Federal
advisory committees. Individuals
appointed to serve as public members of
Federal advisory committees are
classified as special Government
employees (SGEs). SGEs are
Government employees for purposes of
the conflict of interest laws. Therefore,
individuals appointed to serve as public
members of NVAC are subject to an
ethics review. The ethics review is
conducted to determine if the
individual has any interests and/or
activities in the private sector that may
conflict with performance of their
official duties as a member of the
Committee. Individuals appointed to
serve as public members of the
Committee will be required to disclose
information regarding financial
holdings, consultancies, and research
grants and/or contracts.
Dated: December 8, 2008.
Bruce Gellin,
Director, National Vaccine Program Office,
Executive Secretary, National Vaccine
Advisory Committee.
[FR Doc. E8–30614 Filed 12–23–08; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0045] (formerly
Docket No. 2004N–0408)
Regulatory Site Visit Training Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration’s (FDA’s) Center for
Biologics Evaluation and Research
(CBER) is reannouncing the invitation
for participation in its Regulatory Site
Visit Training Program (RSVP). This
training program is intended to give
CBER regulatory review, compliance,
and other relevant staff an opportunity
to visit biologics facilities. These visits
are intended to allow CBER staff to
directly observe routine manufacturing
practices and to give CBER staff a better
understanding of the biologics industry,
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79133
including its challenges and operations.
The purpose of this notice is to invite
biologics facilities to contact CBER for
more information if they are interested
in participating in this program.
DATES: Submit a written or electronic
request for participation in this program
by January 23, 2009. The request should
include a description of your facility
relative to products regulated by CBER.
Please specify the physical address of
the site(s) you are offering.
ADDRESSES: If your biologics facility is
interested in offering a site visit or
learning more about this training
opportunity for CBER staff, or if your
biologics facility responded to a
previous RSVP notice announced in the
Federal Register, you should submit a
request to participate in the program to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic requests to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Lonnie Warren Myers, Division of
Manufacturers Assistance and Training,
Center for Biologics Evaluation and
Research (HFM–49), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX: 301–827–3079,
email: matt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CBER regulates certain biological
products including blood and blood
products, vaccines, and cellular, tissue,
and gene therapies. CBER is committed
to advancing the public health through
innovative activities that help ensure
the safety, effectiveness and timely
delivery of biological products to
patients. To support this primary goal,
CBER has initiated various training and
development programs to promote high
performance of its compliance staff,
regulatory review staff, and other
relevant staff. CBER seeks to
continuously enhance and update
review efficiency and quality, and the
quality of its regulatory efforts and
interactions, by providing CBER staff
with a better understanding of the
biologics industry and its operations.
Further, CBER seeks to improve: (1) Its
understanding of current industry
practices, and regulatory impacts and
needs; and (2) communication between
CBER staff and industry. CBER initiated
its RSVP in 2005, and through these
annual notices, is requesting those firms
that have previously applied and are
still interested in participating, to
reaffirm their interest, as well as
E:\FR\FM\24DEN1.SGM
24DEN1
]]>Agencies
[Federal Register Volume 73, Number 248 (Wednesday, December 24, 2008)]
[Notices]
[Pages 79132-79133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30614]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Nominations for Membership on the National
Vaccine Advisory Committee
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of Public Health and Science.
ACTION: Notice.
-----------------------------------------------------------------------
AUTHORITY: 42 U.S.C. 300aa-5, Section 2105 of the Public Health
Service (PHS) Act, as amended. The Committee is governed by the
provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2),
which sets forth standards for the formation and use of advisory
committees.
SUMMARY: The National Vaccine Program Office (NVPO), a program office
within the Office of Public Health and Science, Department of Health
and Human Services (HHS), is soliciting nominations of qualified
candidates to be considered for appointment as members to the National
Vaccine Advisory Committee (NVAC). The activities of this Committee are
governed by the Federal Advisory Committee Act (FACA). Management
support for the activities of this Committee is the responsibility of
the NVPO.
Consistent with the National Vaccine Plan, the Committee advises
and makes recommendations to the Assistant Secretary for Health in his
capacity as the Director of the National Vaccine Program, on matters
related to the Program's responsibilities. Specifically, the Committee
studies and recommends ways to encourage the availability of an
adequate supply of safe and effective vaccination products in the
United States; recommends research priorities and other measures to
enhance the safety and efficacy of vaccines. The Committee also advises
the Assistant Secretary for Health in the implementation of Sections
2102 and 2103 of the PHS Act; and identifies annually the most
important areas of government and non-government cooperation that
should be considered in implementing Sections 2102 and 2103 of the PHS
Act.
DATES: All nominations for membership on the Committee must be received
no later than 5 p.m. EDT on February 2, 2009, at the address listed
below.
ADDRESSES: All nominations should be mailed or delivered to: Bruce
Gellin, M.D., M.P.H., Executive Secretary, NVAC, Office of Public
Health and Science, Department of Health and Human Services, 200
Independence Avenue, SW., Room 443-H, Hubert H. Humphrey Building;
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Ms. Andrea Krull, Public Health
Advisor, National Vaccine Program Office, Department of Health and
Human Services, 200 Independence Avenue, SW., Room 443-H, Hubert H.
Humphrey Building, Washington, DC 20201; (202) 690-5566; nvpo@hhs.gov.
A copy of the Committee charter which includes the Committee's
structure and functions as well as a list of the current membership can
be obtained by contacting Ms. Krull or by accessing the NVAC Web site
at: https://www.hhs.gov/nvpo/nvac.
SUPPLEMENTARY INFORMATION: Committee Function, Qualifications, and
Information Required: As part of an ongoing effort to enhance
deliberations and discussions with the public on vaccine and
immunization policy, nominations are being sought for interested
individuals to serve on the Committee. Individuals selected for
appointment to the Committee will serve as voting members. The NVAC
consists of 17 voting members. The Committee is composed of 15 public
members, including the Chair, and two representative members. Public
members shall be selected from individuals who are engaged in vaccine
research or the manufacture of vaccines, or who are physicians, members
of parent organizations concerned with immunizations, representatives
of state or local health agencies or public health organizations.
Representative members shall be selected from the vaccine manufacturing
industry who are engaged in vaccine research or the manufacture of
vaccines. Individuals selected for appointment to the Committee can be
invited to serve terms of up to four years.
All NVAC members are authorized to receive the prescribed per diem
allowance and reimbursement for travel expenses that are incurred to
attend meetings and conduct authorized Committee-related business, in
accordance with Standard Government Travel Regulations. Individuals who
are
[[Page 79133]]
appointed to serve as public members are authorized also to receive
honorarium for attending Committee meetings and to carry out other
authorized Committee-related business. Individuals who are appointed to
serve as representative members for a particular interest group or
industry are not authorized to receive honorarium for the performance
of these duties.
This announcement is to solicit nominations of qualified candidates
to fill positions on the NVAC that are scheduled to be vacated in the
public member category. The positions are scheduled to be vacated on
March 31, 2009.
Nominations
In accordance with the charter, persons nominated for appointment
as members of the NVAC should be among authorities knowledgeable in
areas related to vaccine safety, vaccine effectiveness, and vaccine
supply. Nominations should be typewritten. The following information
should be included in the package of material submitted for each
individual being nominated for consideration: (1) A letter of
nomination that clearly states the name and affiliation of the nominee,
the basis for the nomination (i.e., specific attributes which qualify
the nominee for service in this capacity); (2) a statement from the
nominee, bearing an original signature, that, if appointed, he or she
is willing to serve as a member of the Committee; (3) the nominator's
name, address and daytime telephone number, and the home and/or work
address, telephone number, and email address of the individual being
nominated; and (4) a current copy of the nominee's curriculum vitae.
Individuals can nominate themselves for consideration of
appointment to the Committee. All nominations must include the required
information. Incomplete nominations will not be processed for
consideration. The letter from the nominator and certification of the
nominated individual must bear original signatures; reproduced copies
of these signatures are not acceptable. Applications cannot be
submitted by facsimile. The names of Federal employees should not be
nominated for consideration of appointment to this Committee.
The Department makes every effort to ensure that the membership of
HHS Federal advisory committees is fairly balanced in terms of points
of view represented and the committee's function. Every effort is made
that a broad representation of geographic areas, gender, ethnic and
minority groups, and the disabled are given consideration for
membership on HHS Federal advisory committees. Appointment to this
committee shall be made without discrimination on the basis of age,
race, ethnicity, gender, sexual orientation, disability, and cultural,
religious, or socioeconomic status.
The Standards of Ethical Conduct for Employees of the Executive
Branch are applicable to individuals who are appointed as public
members of Federal advisory committees. Individuals appointed to serve
as public members of Federal advisory committees are classified as
special Government employees (SGEs). SGEs are Government employees for
purposes of the conflict of interest laws. Therefore, individuals
appointed to serve as public members of NVAC are subject to an ethics
review. The ethics review is conducted to determine if the individual
has any interests and/or activities in the private sector that may
conflict with performance of their official duties as a member of the
Committee. Individuals appointed to serve as public members of the
Committee will be required to disclose information regarding financial
holdings, consultancies, and research grants and/or contracts.
Dated: December 8, 2008.
Bruce Gellin,
Director, National Vaccine Program Office, Executive Secretary,
National Vaccine Advisory Committee.
[FR Doc. E8-30614 Filed 12-23-08; 8:45 am]
BILLING CODE 4150-44-P
