Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 55397-55398 [2011-22766]
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Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Notices
length of time for which a stay is
requested; and (3) include a statement of
the factual and legal grounds on which
the interested person relies in seeking
the stay. FDA uses the information
provided in the request to determine
whether to grant the petition for stay of
action.
Respondents to this information
collection are interested persons who
choose to file a petition for an
administrative stay of action.
Section 10.85 (21 CFR 10.85), issued
under section 701(a) of the FD&C Act
sets forth the format and procedures by
which an interested person may request,
in accordance with § 10.20 (submission
of documents to Division of Dockets
Management), an advisory opinion from
the Commissioner on a matter of general
applicability. An advisory opinion
represents the formal position of FDA
on a matter of general applicability.
When making a request, the petitioner
must provide a concise statement of the
issues and questions on which an
opinion is requested, and a full
statement of the facts and legal points
relevant to the request. Respondents to
this collection of information are
interested persons seeking an advisory
opinion from the Commissioner on the
Agency’s formal position for matters of
general applicability.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
10.30
10.33
10.35
10.85
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
....................................................................................
....................................................................................
....................................................................................
....................................................................................
207
4
5
4
1
1
1
1
207
4
5
4
24
10
10
16
4,968
40
50
64
Total ..............................................................................
........................
........................
........................
........................
5,122
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
Agency records and experience over the
past 3 years. In 2010, FDA received
approximately 207 petitions (§ 10.30), 4
administrative reconsiderations of
action (§ 10.33), 5 administrative stays
of action (§ 10.35), and 4 advisory
opinions (§ 10.85).
Dated: August 30, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–22857 Filed 9–6–11; 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.
emcdonald on DSK5VPTVN1PROD 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
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17:37 Sep 06, 2011
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recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 16, 2011, from 8 a.m.
to approximately 5:30 p.m.
Location: Hilton Washington DC/
Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD 20910, 301–589–
5200. 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=75dcd91903
204870aff160cb9d5528151d.
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 November 16, 2011, the
committee will meet in open session to
hear an overview of the research
program in the Laboratory of Method
Development, Division of Viral
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Products, Office of Vaccines Research
and Review, Center for Biologics
Evaluation and Research, FDA. The
committee will also hear an update on
the evaluation of Gullian-Barre
Syndrome after Influenza Vaccine
among Medicare population, 2010–
2011. 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 November 16, 2011,
from 8 a.m. to approximately 9:30 a.m.
and from 10:15 a.m. to approximately
5:30 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
November 9, 2011. Oral presentations
from the public will be scheduled
between approximately 3:30 p.m. and
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emcdonald on DSK5VPTVN1PROD with NOTICES
55398
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Notices
4:30 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 November 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
regarding their request to speak by
November 2, 2011.
Closed Committee Deliberations: On
November 16, 2011, between
approximately 9:45 a.m. and 10:15 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
program in the Laboratory of Method
Development 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: August 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy
[FR Doc. 2011–22766 Filed 9–6–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Immunology Devices Panel of the
Medical Devices Advisory Committee:
Notice of Postponement of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is postponing the
meeting of the Immunology Devices
Panel of the Medical Devices Advisory
Committee scheduled for October 14,
2011. The meeting was announced in
the Federal Register of August 9, 2011
(76 FR 48871). The meeting is
postponed so that FDA can review and
consider additional information that
was submitted. Future meeting dates
will be announced in the Federal
Register.
FOR FURTHER INFORMATION CONTACT:
Shanika Craig, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1613, Silver Spring,
MD 20993–0002, 301–796–6639, e-mail:
shanika.craig@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
SUMMARY:
Dated: August 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–22767 Filed 9–6–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
National Institutes of Health,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), HHS.
ACTION: 30-Day notice of submission of
information collection approval from
the Office of Management and Budget
and request for comments.
AGENCY:
As part of a Federal
Government-wide effort to streamline
the process to seek feedback from the
SUMMARY:
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public on service delivery, NICHD has
submitted a Generic Information
Collection Request (Generic ICR):
‘‘Generic Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery ’’ to OMB for approval under
the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.).
DATES: Comments must be submitted
within 30 days after publication in FR.
ADDRESSES: Written comments may be
submitted to the Office of Management
and Budget, Office of Information and
Regulatory Affairs, Attn: NIH Desk
Officer, by E-mail to
OIRA_submission@omb.eop.gov, or by
fax to 202–395–6974.
FOR FURTHER INFORMATION CONTACT: To
request additional information, please
contact Ms. Jamelle Banks, Public
Health Analyst, Office of Science Policy,
Analysis and Communication, National
Institute of Child Health and Human
Development, 31 Center Drive Room
2A18, Bethesda, Maryland 20892, or call
a non-toll free number (301) 496–1877
or E-mail your request, including your
address to banksj@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery.
Abstract: The information collection
activity will garner qualitative customer
and stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
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]]>Agencies
[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Notices]
[Pages 55397-55398]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22766]
-----------------------------------------------------------------------
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 November 16, 2011, from
8 a.m. to approximately 5:30 p.m.
Location: Hilton Washington DC/Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD 20910, 301-589-5200. 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=75dcd91903204870aff160cb9d5528151d.
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 November 16, 2011, the committee will meet in open
session to hear an overview of the research program in the Laboratory
of Method Development, Division of Viral Products, Office of Vaccines
Research and Review, Center for Biologics Evaluation and Research, FDA.
The committee will also hear an update on the evaluation of Gullian-
Barre Syndrome after Influenza Vaccine among Medicare population, 2010-
2011. 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 November 16, 2011, from 8 a.m. to approximately 9:30
a.m. and from 10:15 a.m. to approximately 5:30 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
November 9, 2011. Oral presentations from the public will be scheduled
between approximately 3:30 p.m. and
[[Page 55398]]
4:30 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 November 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 regarding their request to speak by November
2, 2011.
Closed Committee Deliberations: On November 16, 2011, between
approximately 9:45 a.m. and 10:15 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 program in
the Laboratory of Method Development 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: August 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22766 Filed 9-6-11; 8:45 am]
BILLING CODE 4160-01-P
