Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 13646 [2011-5727]
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13646
Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed 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 April 6, 2011, between
approximately 9 a.m. and 4 p.m. and on
April 7, 2011, between approximately
8:30 a.m. and 3:30 p.m.
Location: Hilton Hotel, Washington
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Donald W. Jehn 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), and follow the
prompts to the desired center or product
area. 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 the morning of April 6,
2011, the committee will meet in open
session to hear updates of the research
programs in the Laboratory of Bacterial
Polysaccharides, Division of Bacterial,
Parasitic, and Allergenic Products,
Office of Vaccines Research and Review,
Center for Biologics Evaluation and
Research, FDA. In the afternoon of April
6, 2011, the committee will meet in
open session and will be briefed on the
use of immunological markers for
VerDate Mar<15>2010
16:20 Mar 11, 2011
Jkt 223001
demonstration of effectiveness of
meningococcal serogroups A, C, Y, and
W–135 conjugate vaccines administered
to children less than 2 years of age. On
April 7, 2011, the committee will meet
in open session to review and discuss
approaches to licensure of
meningococcal serogroup B vaccines.
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: On April 6, 2011, from
approximately 9 a.m to 10:50 a.m. and
from approximately 12:30 p.m to 4 p.m.,
the meeting is open to the public. On
April 7, 2011, the entire meeting is open
to the public. 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 March 30, 2011.
Oral presentations from the public will
be scheduled between approximately
10:20 a.m. and 10:50 a.m. and between
approximately 2:30 p.m. and 3 p.m. on
April 6, 2011, and between
approximately 1:30 p.m. and 2 p.m. on
April 7, 2011. Those individuals
interested in making 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 March
22, 2011. 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 March 23, 2011.
Closed Committee Deliberations: On
April 6, 2011, between approximately
10:50 a.m. and 11:30 a.m., the meeting
will be closed to permit discussion
where disclosure would constitute a
clearly unwarranted invasion of
personal privacy (5 U.S.C. 552b(c)(6)).
The committee will discuss the report of
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
the intramural research programs and
make recommendations regarding
personnel staffing decisions.
Persons attending FDA’s advisory
committee meetings are advised that the
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 Donald W.
Jehn 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: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5727 Filed 3–11–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Delegation of Authority
Notice is hereby given that I have
delegated to the Administrator, Health
Resources and Services Administration
(HRSA), authority vested in the
Secretary under Title XX, Section
2008(b) of the Social Security Act (42
U.S.C. 1397g(b)), as added by Section
5507(a) of the Affordable Care Act, as it
pertains to the functions assigned to
HRSA. This authority may be
redelegated.
HRSA will consult with the Assistant
Secretary for Planning and Evaluation,
as appropriate, in implementing this
authority.
This delegation excludes the authority
to issue regulations, to establish
advisory councils and committees and
appoint their members, and to submit
reports to Congress, and shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidelines. In addition,
I hereby affirm and ratify any actions
taken by the Administrator, HRSA, or
other HRSA officials, which involved
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Page 13646]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5727]
[[Page 13646]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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). At least one
portion of the meeting will be closed 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 April 6, 2011, between
approximately 9 a.m. and 4 p.m. and on April 7, 2011, between
approximately 8:30 a.m. and 3:30 p.m.
Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Donald W. Jehn 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), and follow the prompts to the desired
center or product area. 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 the morning of April 6, 2011, the committee will meet in
open session to hear updates of the research programs in the Laboratory
of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and
Allergenic Products, Office of Vaccines Research and Review, Center for
Biologics Evaluation and Research, FDA. In the afternoon of April 6,
2011, the committee will meet in open session and will be briefed on
the use of immunological markers for demonstration of effectiveness of
meningococcal serogroups A, C, Y, and W-135 conjugate vaccines
administered to children less than 2 years of age. On April 7, 2011,
the committee will meet in open session to review and discuss
approaches to licensure of meningococcal serogroup B vaccines.
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: On April 6, 2011, from approximately 9 a.m to 10:50 a.m.
and from approximately 12:30 p.m to 4 p.m., the meeting is open to the
public. On April 7, 2011, the entire meeting is open to the public.
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 March 30, 2011. Oral
presentations from the public will be scheduled between approximately
10:20 a.m. and 10:50 a.m. and between approximately 2:30 p.m. and 3
p.m. on April 6, 2011, and between approximately 1:30 p.m. and 2 p.m.
on April 7, 2011. Those individuals interested in making 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 March 22, 2011. 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 March 23,
2011.
Closed Committee Deliberations: On April 6, 2011, between
approximately 10:50 a.m. and 11:30 a.m., the meeting will be closed to
permit discussion where disclosure would constitute a clearly
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the report of the intramural research programs
and make recommendations regarding personnel staffing decisions.
Persons attending FDA's advisory committee meetings are advised
that the 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 Donald W. Jehn 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: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5727 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P
