Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 41449-41450 [E9-19639]
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Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Immune Protection to
Highly Lethal Pathogens by CD45
Modulation.
Date: September 9, 2009.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge 6700, 6700B Rockledge Drive,
Bethesda, MD 20817 (Telephone Conference
Call).
Contact Person: Raymond Richard Schleef,
PhD, Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institutes of Health/
NIAID, 6700B Rockledge Drive, MSC 7616,
Bethesda, MD 20892–7616, 301–451–3679,
schleefrr@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 11, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19687 Filed 8–14–09; 8:45 am]
Natl Inst of Dental and Craniofacial Research,
National Institutes of Health, Bethesda, MD
20892.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Information is also available on the
Institute’s/Center’s home page: https://
www.nidcr.nih.gov/about, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: August 11, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19686 Filed 8–14–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
BILLING CODE 4140–01–P
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
ACTION:
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
mstockstill on DSKH9S0YB1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Dental and
Craniofacial Research Council.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Dental and Craniofacial Research Council.
Date: August 31, 2009.
Time: 12 p.m. to 1 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Alicia J. Dombroski, PhD,
Director, Division of Extramural Activities,
VerDate Nov<24>2008
17:55 Aug 14, 2009
Food and Drug Administration,
HHS.
National Institutes of Health
Jkt 217001
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Vaccines and
Related Biological Products Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 9, 2009, from 8 a.m.
to approximately 5 p.m.
Location: Hilton Hotel, Washington
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512391. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
PO 00000
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41449
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On September 9, 2009, in the
morning, the committee will discuss
and make recommendations on the
safety and effectiveness in females of a
vaccine manufactured by
GlaxoSmithKline against Human
Papillomavirus. In the afternoon, the
committee will discuss and make
recommendations on the safety and
effectiveness of vaccinating males with
Gardasil, a vaccine manufactured by
Merck & Co. against Human
Papillomavirus.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: 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 September 4, 2009.
Oral presentations from the public will
be scheduled between approximately
11:30 a.m. and 12 noon and between
approximately 3:40 p.m. and 4:10 p.m.
Those desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before August
27, 2009. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by September 3, 2009.
Persons attending FDA’s advisory
committee meetings are advised that the
E:\FR\FM\17AUN1.SGM
17AUN1
41450
Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Christine
Walsh or Denise Royster at least 7 days
in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 11, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–19639 Filed 8–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
mstockstill on DSKH9S0YB1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Heart, Lung, and Blood Advisory
Council.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Advisory Council.
Date: September 1, 2009.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, C-Wing, Room
10, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Stephen C. Mockrin, PhD,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
VerDate Nov<24>2008
17:55 Aug 14, 2009
Jkt 217001
Rockledge Drive, Room 7100, Bethesda, MD
20892, (301) 435–0260,
mockrins@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Advisory Council.
Date: September 15, 2009.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, A-Wing, Room
5A05, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Stephen C. Mockrin, PhD,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7100, Bethesda, MD
20892, (301) 435–0260,
mockrins@nhlbi.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
www.nhlbi.nih.gov/meetings/index.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research; 93.701, ARRA
Related Biomedical Research and Research
Support Awards, National Institutes of
Health, HHS)
Dated: August 10, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19577 Filed 8–14–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Advisory Board on Radiation and
Worker Health (ABRWH or Advisory
Board), National Institute for
Occupational Safety and Health
(NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention announces the
following committee meeting:
Time and Date: 11 a.m.–2 p.m., Tuesday,
September 8, 2009.
Place: Audio Conference Call via FTS
Conferencing. The USA toll free dial in
number is 1–866–659–0537 with a pass code
of 9933701.
Status: Open to the public, but without a
public comment period.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation Program
Act of 2000 to advise the President on a
variety of policy and technical functions
PO 00000
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required to implement and effectively
manage the new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines which
have been promulgated by the Department of
Health and Human Services (HHS) as a final
rule, advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule, advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
program, and advice on petitions to add
classes of workers to the Special Exposure
Cohort (SEC).
In December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS, which
subsequently delegated this authority to the
CDC. NIOSH implements this responsibility
for CDC. The charter was issued on August
3, 2001, renewed at appropriate intervals,
will expire on August 3, 2011.
Purpose: This Advisory Board is charged
with (a) providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advising the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
endangered the health of members of this
class.
Matters To Be Discussed: The agenda for
the conference call includes: Blockson
Chemical Company Radon Model Validation;
Board Subcommittee and Work Group
Updates; Board Working Groups Transcripts
Reviews; OCAS SEC Petition Evaluations
Update for October Board Meeting; DOL
Consideration of OCAS Ruttenber Data
Review.
The agenda is subject to change as
priorities dictate.
Because there is not a public comment
period, written comments may be submitted.
Any written comments received will be
included in the official record of the meeting
and should be submitted to the contact
person below in advance of the meeting.
Contact Person for More Information:
Theodore M. Katz, M.P.A., Executive
Secretary, NIOSH, CDC, 1600 Clifton Rd. NE.,
Mailstop: E–20, Atlanta, GA 30333,
Telephone (513) 533–6800, Toll Free 1–800–
CDC–INFO, E-mail ocas@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
E:\FR\FM\17AUN1.SGM
17AUN1
]]>Agencies
[Federal Register Volume 74, Number 157 (Monday, August 17, 2009)]
[Notices]
[Pages 41449-41450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19639]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Vaccines and Related Biological Products
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 9, 2009, from
8 a.m. to approximately 5 p.m.
Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Christine Walsh or Denise Royster, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512391. Please call the
Information Line 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. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On September 9, 2009, in the morning, the committee will
discuss and make recommendations on the safety and effectiveness in
females of a vaccine manufactured by GlaxoSmithKline against Human
Papillomavirus. In the afternoon, the committee will discuss and make
recommendations on the safety and effectiveness of vaccinating males
with Gardasil, a vaccine manufactured by Merck & Co. against Human
Papillomavirus.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: 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
September 4, 2009. Oral presentations from the public will be scheduled
between approximately 11:30 a.m. and 12 noon and between approximately
3:40 p.m. and 4:10 p.m. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before August 27, 2009. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by September
3, 2009.
Persons attending FDA's advisory committee meetings are advised
that the
[[Page 41450]]
agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Christine Walsh or
Denise Royster at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 11, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-19639 Filed 8-14-09; 8:45 am]
BILLING CODE 4160-01-S
