Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 44016-44017 [2011-18506]
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mstockstill on DSK4VPTVN1PROD with NOTICES
44016
Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices
PEI is an institution of the Federal
Republic of Germany. PEI reports to the
¨
Bundesministerium fur Gesundheit
(Federal Ministry of Health). Most of its
activities relate to provisions in German
and European medicinal product
legislation, such as the approval of
clinical trials and the marketing
authorization of particular groups of
medicinal products. Since its
foundation more than 100 years ago, PEI
has concentrated on many biological
medicinal products, including vaccines
for humans and animals, medicinal
products containing antibodies,
allergens for therapy and diagnostics,
blood and blood products, and more
recently, tissue and medicinal products
for gene therapy, somatic cell therapy,
and xenogenic cell therapy.
DIA is a nonprofit, multidisciplinary,
member-driven scientific association
with a membership of over 22,000.
These members are primarily from the
regulatory Agencies, academia, contract
service organizations, pharmaceutical,
biological and device industry, and from
other health care organizations. DIA
provides a neutral global forum for the
exchange and dissemination of
knowledge on the discovery,
development, evaluation, and
utilization of medicines and related
health care technologies. Through these
activities, DIA provides development
opportunities for its members.
The public workshop will feature
presentations by FDA and regulators
from Canada, China, Europe, and
Mexico. The public workshop will begin
with a keynote address by Harold S.
Nelson and end with a closing address
by N. Franklin Adkinson, Jr. During the
public workshop, the following topics
will be discussed:
• Standardization and
characterization of natural allergenic
products;
• Methods in product and study
design of effective allergenic products
for therapy;
• Standardization and
characterization of modified and
recombinant allergenic products;
• Immunological mechanisms of
allergy immunotherapy;
• Immunotherapy with purified
allergen components;
• Extrinsic adjuvants in the use of
allergen immunotherapy;
• Immunomodulatory properties of
allergens; and
• State-of-the-art of immunotherapy
in different allergic diseases.
DIA will provide all seminar
attendees with a Web link no later than
4 weeks post-seminar. The Web link
will provide access to approved Portable
Document Format (PDF) presentations.
VerDate Mar<15>2010
17:59 Jul 21, 2011
Jkt 223001
The Web link will be available for
approximately 6 months postseminar.
Dated: July 19, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–18534 Filed 7–21–11; 8:45 am]
BILLING CODE 4160–01–P
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 September 20, 2011, from 8 a.m.
to approximately 5:15 p.m.
Location: Hilton Hotel, Washington
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20977, 301–
977–8900. For those unable to attend in
person, the meeting will also be Web
cast. The link for the Web cast is
available at https://fda.yorkcast.com/
webcast/Viewer/?peid=
84f95996804743439bcc5be
69d1908051d.
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
PO 00000
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hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On September 20, 2011, the
committee will meet in open session to
hear an overview of the research
program in the Laboratory of Enteric
and Sexually Transmitted Diseases,
Division of Bacterial, Parasitic and
Allergenic Products, Office of Vaccines
Research and Review, Center for
Biologics Evaluation and Research,
FDA. The committee will then discuss
and make recommendations on the
safety and immunogenicity (surrogate
endpoint) of Pneumococcal 13-valent
conjugate vaccine (Diphtheria CRM197
Protein) in adults aged 50 years and
older using an accelerated approval
regulatory pathway.
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 September 20, 2011,
between approximately 8 a.m. and
10 a.m., and between approximately
10:45 a.m. and 5:15 p.m., the 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 September 13, 2011.
Oral presentations from the public will
be scheduled between approximately
9:30 a.m. and 10 a.m. and between
approximately 3:45 p.m. and 4:15 p.m.
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 September 1, 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
E:\FR\FM\22JYN1.SGM
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Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices
regarding their request to speak by
September 2, 2011.
Closed Committee Deliberations: On
September 20, 2011, between
approximately 10:15 a.m. and 10:45
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/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: July 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–18506 Filed 7–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Risk Communication Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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: Risk
Communication Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
VerDate Mar<15>2010
17:59 Jul 21, 2011
Jkt 223001
Date and Time: The meeting will be
held on August 15, 2011, from 8 a.m. to
5 p.m. and August 16, 2011, from 8 a.m.
to 2 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You’’, click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Lee L. Zwanziger,
Office of Policy, Planning and Budget,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
3278, Silver Spring, MD 20993, 301–
796–9151, FAX: 301–847–8611, e-mail:
RCAC@fda.hhs.gov, 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 August 15, 2011, the
Committee will discuss challenges of
communicating about evolving
methodology in the attribution of
foodborne illness. Estimating the
number of illnesses, hospitalizations,
and deaths caused by major pathogens
is the first step in the development of
disease prevention strategies. Estimating
the proportions of these illnesses due to
specific food sources (food source
attribution) is a necessary second step
towards identifying the sources that
cause substantial preventable human
illness and measuring progress toward
public health goals resulting from
public health interventions applied to
those food sources. Consequently, FDA,
the Centers for Disease Control and
Prevention, and the U.S. Department of
Agriculture/Food Safety Inspection
Service have begun a joint initiative,
called the Interagency Food Safety
Analytics Collaboration (IFSAC), to
improve our collective understanding of
source attribution of infections to
specific foods and settings. While the
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44017
IFSAC works to improve methodology,
we are also committed to keeping
stakeholders informed and engaged, and
are seeking advice about how to
communicate most effectively. On
August 16, 2011, the Committee will
present ‘‘Communicating Risks and
Benefits: An Evidence-Based User’s
Guide.’’ This volume is the result of
work, as discussed in previous
meetings, by current and former
members of the Risk Communication
Advisory Committee.
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 August 10, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on August 15, 2011, and
10:30 a.m. and 11:30 a.m. on August 16,
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 August 2, 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 August 3, 2011.
Interested persons can also log on to
https://collaboration.fda.gov/rcac/ to
hear and see the proceedings.
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
E:\FR\FM\22JYN1.SGM
22JYN1
]]>Agencies
[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44016-44017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18506]
-----------------------------------------------------------------------
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 September 20, 2011, from
8 a.m. to approximately 5:15 p.m.
Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20977, 301-977-8900. For those unable to attend
in person, the meeting will also be Web cast. The link for the Web cast
is available at https://fda.yorkcast.com/webcast/Viewer/?peid=84f95996804743439bcc5be69d1908051d.
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 September 20, 2011, the committee will meet in open
session to hear an overview of the research program in the Laboratory
of Enteric and Sexually Transmitted Diseases, Division of Bacterial,
Parasitic and Allergenic Products, Office of Vaccines Research and
Review, Center for Biologics Evaluation and Research, FDA. The
committee will then discuss and make recommendations on the safety and
immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate
vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older
using an accelerated approval regulatory pathway.
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 September 20, 2011, between approximately 8 a.m. and
10 a.m., and between approximately 10:45 a.m. and 5:15 p.m., the
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 September 13, 2011. Oral presentations from the public will
be scheduled between approximately 9:30 a.m. and 10 a.m. and between
approximately 3:45 p.m. and 4:15 p.m. 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 September 1, 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
[[Page 44017]]
regarding their request to speak by September 2, 2011.
Closed Committee Deliberations: On September 20, 2011, between
approximately 10:15 a.m. and 10:45 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: July 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-18506 Filed 7-21-11; 8:45 am]
BILLING CODE 4160-01-P
