Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 32614 [E9-16099]
Download as PDF
32614
Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices
registry are: (1) Continue to identify and
enroll patients with CFS and other
unexplained fatiguing illnesses who are
receiving medical and ancillary medical
care and describe their epidemiologic
and clinical characteristics; (2) assess
and monitor the health care providers’
knowledge, attitudes, and beliefs
concerning CFS; (3) and to identify
well-characterized CFS patients for
future clinical studies and intervention
trials. These specific aims require
inclusion of subjects in early stages of
CFS (i.e., ill less than one year duration)
who can be followed longitudinally to
assess changes in their CFS symptoms;
persons with longer duration of fatigue
will also be eligible.
There is no cost to respondents other
than their time.
ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of
respondents
Respondent
Number of
responses per
respondent
Average
burden per
response
(hours)
Total burden
(hours)
Referring Providers ..........................................................................................
Patient consent to be contacted ......................................................................
Patient Telephone Interview ............................................................................
Patient Clinical Evaluation ...............................................................................
200
340
289
221
2
1
1
1
5/60
10/60
44/60
9
33
57
212
1,989
Total Burden .............................................................................................
........................
........................
........................
2,291
Dated: June 30, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–16141 Filed 7–7–09; 8:45 am]
BILLING CODE 4163–18–P
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.
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). 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 July 23, 2009, from 8 a.m. to
approximately 4 p.m.
Location: Hilton Hotel Washington
DC North/Gaithersburg, Montgomery
Ballroom, 620 Perry Pkwy.,
Gaithersburg, MD 20877.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–827–
0314, or FDA Advisory Committee
VerDate Nov<24>2008
17:23 Jul 07, 2009
Jkt 217001
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: The committee will discuss
clinical trials to support use of vaccines
against the 2009 H1N1 influenza virus.
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, click on the year 2009 and
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 July 16, 2009. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 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
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
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 July 15, 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 July 9, 2009.
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/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: June 29, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–16099 Filed 7–7–09; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\08JYN1.SGM
08JYN1
Agencies
[Federal Register Volume 74, Number 129 (Wednesday, July 8, 2009)]
[Notices]
[Page 32614]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16099]
-----------------------------------------------------------------------
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 July 23, 2009, from 8
a.m. to approximately 4 p.m.
Location: Hilton Hotel Washington DC North/Gaithersburg, Montgomery
Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877.
Contact Person: Christine Walsh or Denise Royster, Center for
Biologics Evaluation and Research, 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: The committee will discuss clinical trials to support use
of vaccines against the 2009 H1N1 influenza virus.
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, click on the year 2009 and 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 July
16, 2009. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 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 July 15, 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 July 9,
2009.
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/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: June 29, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-16099 Filed 7-7-09; 8:45 am]
BILLING CODE 4160-01-S