Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 65386-65387 [E8-26139]
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65386
Federal Register / Vol. 73, No. 213 / Monday, November 3, 2008 / Notices
submitted to the agency in triplicate
with the appropriate form attached,
either Form FDA 1571 or Form FDA
356h. The agency recommends that a
request be submitted as an amendment
in this manner for two reasons: (1) To
ensure that each request is kept in the
administrative file with the entire
underlying application and (2) to ensure
that pertinent information about the
request is entered into the appropriate
tracking databases. Use of the
information in the agency’s tracking
databases enables the appropriate
agency official to monitor progress on
the resolution of the dispute and to
ensure that appropriate steps will be
taken in a timely manner.
CDER and CBER have determined and
the guidance recommends that the
following information should be
submitted to the appropriate center with
each request for dispute resolution so
that the Center may quickly and
efficiently respond to the request: (1) A
brief but comprehensive statement of
each issue to be resolved, including a
description of the issue; the nature of
the issue (i.e., scientific, procedural, or
both); possible solutions based on
information in the administrative file;
whether informal dispute resolution
was sought prior to the formal appeal;
whether advisory committee review is
sought; and the expected outcome; (2) a
statement identifying the review
division/office that issued the original
decision on the matter and, if
applicable, the last agency official that
attempted to formally resolve the
matter; (3) a list of documents in the
administrative file, or additional copies
of such documents, that are deemed
necessary for resolution of the issue(s);
and (4) a statement that the previous
supervisory level has already had the
opportunity to review all of the material
relied on for dispute resolution. The
information that the agency suggests
submitting with a formal request for
dispute resolution consists of: (1)
Statements describing the issue from the
perspective of the person with a
dispute, (2) brief statements describing
the history of the matter, and (3) the
documents previously submitted to FDA
under an OMB approved collection of
information.
Based on FDA’s experience with
dispute resolution, the agency expects
that most persons seeking formal
dispute resolution will have gathered
the materials listed previously when
identifying the existence of a dispute
with the agency. Consequently, FDA
anticipates that the collection of
information attributed solely to the
guidance will be minimal.
Description of Respondents: A
sponsor, applicant, or manufacturer of a
drug or biological product regulated by
the agency under the Federal Food,
Drug, and Cosmetic Act or section 351
of the Public Health Service Act who
requests formal resolution of a scientific
or procedural dispute.
Burden Estimate: Provided in table 1
of this document is an estimate of the
annual reporting burden for requests for
dispute resolution. Based on data
collected from review divisions and
offices within CDER and CBER, FDA
estimates that approximately 13
sponsors and applicants (respondents)
submit requests for formal dispute
resolution to CDER annually and
approximately 1 respondent submits
requests for formal dispute resolution to
CBER annually. The total annual
responses are the total number of
requests submitted to CDER and CBER
in 1 year, including requests for dispute
resolution that a single respondent
submits more than one time. FDA
estimates that CDER receives
approximately 22 requests annually and
CBER receives approximately 1 request
annually. The hours per response is the
estimated number of hours that a
respondent would spend preparing the
information to be submitted with a
request for formal dispute resolution in
accordance with the guidance,
including the time it takes to gather and
copy brief statements describing the
issue from the perspective of the person
with the dispute, brief statements
describing the history of the matter, and
supporting information that has already
been submitted to the agency. Based on
experience, FDA estimates that
approximately 8 hours on average
would be needed per response.
Therefore, FDA estimates that 184 hours
will be spent per year by respondents
requesting formal dispute resolution
under the guidance.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Requests for Formal Dispute
Resolution
No. of
Respondents
No. of Responses
per Respondent
Total Annual
Responses
Hours Per
Response
Total Hours
CDER
13
1.7
22
8
176
CBER
1
1
1
8
8
Total
1 There
184
are no capital costs or operating and maintenance costs associated with this collection of information.
sroberts on PROD1PC70 with NOTICES
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: October 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–26095 Filed 10–31–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
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
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sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 213 / Monday, November 3, 2008 / Notices
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 20, 2008, from 1 p.m.
to approximately 4 p.m.
Location: National Institutes of
Health, Building 29B, Conference Room
C. This meeting will be held by
teleconference. The public is welcome
to attend the meeting at the specified
location where a speakerphone will be
provided. Public participation in the
meeting is limited to the use of the
speakerphone in the conference room.
Important information about
transportation and directions to the NIH
campus, parking, and security
procedures is available on the Internet
at https://www.nih.gov/about/visitor/
index.htm. Visitors must show two
forms of identification, one of which
must be a government-issued photo
identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. Detailed
information about security procedures is
located at https://www.nih.gov/about/
visitorsecurity.htm. Due to the limited
available parking, visitors are
encouraged to use public transportation.
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 November 20, 2008, the
Committee will meet in open session to
hear updates of the research program in
the Laboratory of DNA Viruses, Division
of Viral Products, Center for Biologics
Evaluation and Research, FDA.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
VerDate Aug<31>2005
16:58 Oct 31, 2008
Jkt 217001
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: On November 20, 2008,
from 1 p.m. to approximately 3:30 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 13, 2008. Oral presentations
from the public will be scheduled
between approximately 2:30 p.m. and
3:30 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 November 5, 2008. 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 6, 2008.
Closed Committee Deliberations: On
November 20, 2008, from approximately
3:30 p.m. to 4 p.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 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 Christine
Walsh or Denise Royster at least 7 days
in advance of the meeting.
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65387
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Dated: October 21, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–26139 Filed 10–31–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Follow-Up of Kidney Cancer
Patients From the Central European
Multicenter Case-Control Study
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Follow-up
of Kidney Cancer Patients from the
Central European Multicenter CaseControl Study. Type of Information
Collection Request: New. Need and Use
of Information Collection: The purpose
of this questionnaire is to obtain
information on the 5-year survival status
of kidney cancer patients that were
enrolled in a Central European CaseControl Study of Kidney Cancer that
was conducted between 2001–2004. The
aim is to assess survival, the prevalence
of recurrent disease and progression,
and to investigate patient, tumor and
genetic determinants of survival among
cases. The questionnaire will collect
information on patient related factors,
tumor related factors not collected
during the initial study, and the type of
treatment(s) received since the patients
were last contacted for the case-control
study. This questionnaire adheres to
The Public Health Service Act, section
412 (42 U.S.C. 285a–1) and section 413
(42 U.S.C. 285a–2), which authorizes
the Division of Cancer Epidemiology
and Genetics of the National Cancer
Institute (NCI) to establish and support
programs for the detection, diagnosis,
prevention and treatment of cancer; and
to collect, identify, analyze and
disseminate information on cancer
research, diagnosis, prevention and
E:\FR\FM\03NON1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 213 (Monday, November 3, 2008)]
[Notices]
[Pages 65386-65387]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26139]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
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
[[Page 65387]]
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 20, 2008, from
1 p.m. to approximately 4 p.m.
Location: National Institutes of Health, Building 29B, Conference
Room C. This meeting will be held by teleconference. The public is
welcome to attend the meeting at the specified location where a
speakerphone will be provided. Public participation in the meeting is
limited to the use of the speakerphone in the conference room.
Important information about transportation and directions to the NIH
campus, parking, and security procedures is available on the Internet
at https://www.nih.gov/about/visitor/index.htm. Visitors must show two
forms of identification, one of which must be a government-issued photo
identification such as a Federal employee badge, driver's license,
passport, green card, etc. Detailed information about security
procedures is located at https://www.nih.gov/about/visitorsecurity.htm.
Due to the limited available parking, visitors are encouraged to use
public transportation.
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 November 20, 2008, the Committee will meet in open
session to hear updates of the research program in the Laboratory of
DNA Viruses, Division of Viral Products, Center for Biologics
Evaluation and Research, FDA.
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/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
Procedure: On November 20, 2008, from 1 p.m. to approximately 3:30
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 13, 2008. Oral presentations from the
public will be scheduled between approximately 2:30 p.m. and 3:30 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 November 5, 2008.
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 6, 2008.
Closed Committee Deliberations: On November 20, 2008, from
approximately 3:30 p.m. to 4 p.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 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 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/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
Dated: October 21, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26139 Filed 10-31-08; 8:45 am]
BILLING CODE 4160-01-S
