Advisory Commission on Childhood Vaccines; Notice of Meeting, 40207-40208 [E9-19109]
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Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
General Medical Sciences Special
Emphasis Panel, August 17, 2009, 8 a.m.
to August 17, 2009, 5 p.m., National
Institutes of Health, Natcher Building,
Room 3AN12, 45 Center Drive,
Bethesda, MD, 20892 which was
published in the Federal Register on
July 24, 2009, 74 FR 36728.
The meeting has been changed from
August 17, 2009 to August 20, 2009. The
meeting is closed to the public.
Dated: August 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19091 Filed 8–10–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Joint Meeting of the Anesthetic and
Life Support Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD 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 Committees: Anesthetic and
Life Support Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 23, 2009, from 8 a.m.
to 4:30 p.m.
Location: Holiday Inn, The Ballrooms,
Two Montgomery Village Ave.,
Gaithersburg, MD. The hotel phone
number is 301–948–8900.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane, (for express delivery,
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5630 Fishers Lane, rm. 1093, Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail:
Kalyani.Bhatt@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in
Washington, DC area), codes
3014512529 or 3014512535. 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 hotline/phone line
to learn about possible modifications
before coming to the meeting.
Agenda: The committees will discuss
new drug application (NDA) 21–217,
EXALGO (hydromorphone HCl), a
modified-release hydromorphone drug
product indicated for the treatment of
moderate-to-severe pain in opioidtolerant patients.
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 September 9, 2009.
Oral presentations from the public will
be scheduled between approximately 1
p.m. to 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 September 1, 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
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40207
regarding their request to speak by
September 2, 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 Kalyani
Bhatt 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/AboutAdvisory
Committees/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 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–19105 Filed 8–10–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Commission on
Childhood Vaccines (ACCV).
Date and Time: September 17, 2009, 1 p.m.
to 5:30 p.m. EDT; September 18, 9 a.m. to 12
p.m. EDT.
Place: Parklawn Building (and via audio
conference call), Conference Rooms G & H,
5600 Fishers Lane, Rockville, MD 20857.
The ACCV will meet on Thursday,
September 17 from 1 p.m. to 5:30 p.m. (EDT)
and Friday, September 18 from 9 a.m. to 12
p.m. (EDT). The public can join the meeting
via audio conference call by dialing 1–800–
369–1791 on September 17 & 18 and
providing the following information:
Leader’s Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the June
meeting will include, but are not limited to:
Updates from the Division of Vaccine Injury
Compensation (DVIC), Department of Justice,
National Vaccine Program Office,
Immunization Safety Office (Centers for
Disease Control and Prevention), National
Institute of Allergy and Infectious Diseases
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40208
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
(National Institutes of Health), Center for
Biologics, Evaluation and Research (Food
and Drug Administration), a discussion on
causation, and an update from the IOM on
the project to review adverse effects of
vaccines. Agenda items are subject to change
as priorities dictate.
Public Comments: Persons interested in
providing an oral presentation should submit
a written request, along with a copy of their
presentation to: Kay Cook, DVIC, Healthcare
Systems Bureau (HSB), Health Resources and
Services Administration (HRSA), Room 11C–
26, 5600 Fishers Lane, Rockville, Maryland
20857 or e-mail: kcook@hrsa.gov. Requests
should contain the name, address, telephone
number, and any business or professional
affiliation of the person desiring to make an
oral presentation. Groups having similar
interests are requested to combine their
comments and present them through a single
representative. The allocation of time may be
adjusted to accommodate the level of
expressed interest. DVIC will notify each
presenter by mail or telephone of their
assigned presentation time. Persons who do
not file an advance request for a presentation,
but desire to make an oral statement, may
announce it at the time of the comment
period. These persons will be allocated time
as it permits.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the ACCV should contact Kay Cook,
DVIC, HSB, HRSA, Room 11C–26, 5600
Fishers Lane, Rockville, MD 20857;
telephone (301) 443–6593 or e-mail:
kcook@hrsa.gov.
Dated: August 4, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–19109 Filed 8–10–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Notice of Meeting; National
Commission on Children and Disasters
sroberts on DSKD5P82C1PROD with NOTICES
AGENCY: Administration for Children
and Families, Department of Health and
Human Services.
ACTION: Notice of meeting.
DATES: The meeting will be held on
Tuesday, September 15, 2009, from 9:30
a.m. to 3:30 p.m.
ADDRESSES: The meeting will be held at
the Administration for Children and
Families, 901 D Street, SW.,
Washington, DC 20024. To attend either
in person or via teleconference, please
register by 5 p.m., Eastern Time,
September 11, 2009. To register, please
e-mail capelt@acf.hhs.gov with
‘‘Meeting Registration’’ in the subject
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line, or call (202) 205–9560. Registration
must include your name, affiliation, and
phone number. If you require a signlanguage interpreter or other special
assistance, please call Carol Apelt at
(202) 205–4618 as soon as possible and
no later than 5 p.m., Eastern Time,
September 1, 2009.
Agenda: The Commission will hear
reports from four subcommittees: (1)
Pediatric Medical Care Subcommittee;
(2) Education, Child Welfare, and
Juvenile Justice Subcommittee; (3)
Evacuation, Transportation and Housing
Subcommittee; and (4) Human Services
Recovery Subcommittee. The
Commission will also deliberate and
vote on its Interim Report to the
President and Congress.
Written comments may be submitted
electronically to
roberta.lavin@acf.hhs.gov with ‘‘Public
Comment’’ in the subject line. The
Commission recommends that you
include your name, mailing address and
an email address or other contact
information in the body of your
comment. This ensures that you can be
identified as the submitter of the
comment, and it allows the Commission
to contact you if further information on
the substance of your comment is
needed or if your comment cannot be
read due to technical difficulties. The
Commission’s policy is that the
Commission will not edit your
comment, and any identifying or contact
information provided in the body of a
comment will be included as part of the
comment placed in the official record.
The Commission will provide an
opportunity for public comments during
the public meeting on September 15,
2009. Those wishing to speak will be
limited to three minutes each; speakers
are encouraged to submit their remarks
in writing in advance to ensure their
comment is received in case there is
inadequate time for all comments to be
heard on September 15, 2009.
Additional Information: Contact
Roberta Lavin, Office of Human Services
Emergency Preparedness and Response,
e-mail roberta.lavin@acf.hhs.gov or
phone (202) 401–9306.
SUPPLEMENTARY INFORMATION: The
National Commission on Children and
Disasters is an independent Commission
that shall conduct a comprehensive
study to examine and assess the needs
of children as they relate to preparation
for, response to, and recovery from all
hazards, building upon the evaluations
of other entities and avoiding
unnecessary duplication by reviewing
the findings, conclusions, and
recommendations of these entities. The
Commission shall then submit a report
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to the President and Congress on the
Commission’s independent and specific
findings, conclusions, and
recommendations to address the needs
of children as they relate to preparation
for, response to, and recovery from all
hazards, including major disasters and
emergencies.
Dated: August 3, 2009.
David A. Hansell,
Acting Assistant Secretary for Children and
Families.
[FR Doc. E9–19157 Filed 8–10–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Council on Blood Stem
Cell Transplantation.
Date and Times: September 21, 2009, 8:30
a.m. to 4:30 p.m.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, Bethesda, Maryland
20814.
Status: The meeting will be open to the
public.
Purpose: Pursuant to Public Law 109–129,
42 U.S.C. 274k (section 379 of the Public
Health Service Act, as amended) the
Advisory Council on Blood Stem Cell
Transplantation (ACBSCT) advises the
Secretary of HHS and the Administrator,
HRSA, on matters related to the activities of
the C.W. Bill Young Cell Transplantation
Program (Program) and the National Cord
Blood Inventory (NCBI) Program.
Agenda:
The Council will hear reports from three
ACBSCT Work Groups: Informed Consent,
Access to Transplantation, and Cord Blood
Collections. The Council also will hear
presentations and discussions on the
following topics: Induced pluripotent stem
cells and adult stem cells, National Marrow
Donor Program Infrastructure Summit,
Radiation Injury Treatment Network, and
trends in post-transplant survival. Agenda
items are subject to change as priorities
indicate.
After the presentations and Council
discussions, members of the public will have
an opportunity to provide comments.
Because of the Council’s full agenda and the
timeframe in which to cover the agenda
topics, public comment will be limited. All
public comments will be included in the
record of the ACBSCT meeting. Meeting
summary notes will be made available on the
HRSA’s Program Web site at https://bloodcell.
transplant.hrsa.gov/ABOUT/Advisory_
Council/.
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[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Pages 40207-40208]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Commission on Childhood Vaccines; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: Advisory Commission on Childhood Vaccines (ACCV).
Date and Time: September 17, 2009, 1 p.m. to 5:30 p.m. EDT;
September 18, 9 a.m. to 12 p.m. EDT.
Place: Parklawn Building (and via audio conference call),
Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857.
The ACCV will meet on Thursday, September 17 from 1 p.m. to 5:30
p.m. (EDT) and Friday, September 18 from 9 a.m. to 12 p.m. (EDT).
The public can join the meeting via audio conference call by dialing
1-800-369-1791 on September 17 & 18 and providing the following
information:
Leader's Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the June meeting will include, but
are not limited to: Updates from the Division of Vaccine Injury
Compensation (DVIC), Department of Justice, National Vaccine Program
Office, Immunization Safety Office (Centers for Disease Control and
Prevention), National Institute of Allergy and Infectious Diseases
[[Page 40208]]
(National Institutes of Health), Center for Biologics, Evaluation
and Research (Food and Drug Administration), a discussion on
causation, and an update from the IOM on the project to review
adverse effects of vaccines. Agenda items are subject to change as
priorities dictate.
Public Comments: Persons interested in providing an oral
presentation should submit a written request, along with a copy of
their presentation to: Kay Cook, DVIC, Healthcare Systems Bureau
(HSB), Health Resources and Services Administration (HRSA), Room
11C-26, 5600 Fishers Lane, Rockville, Maryland 20857 or e-mail:
kcook@hrsa.gov. Requests should contain the name, address, telephone
number, and any business or professional affiliation of the person
desiring to make an oral presentation. Groups having similar
interests are requested to combine their comments and present them
through a single representative. The allocation of time may be
adjusted to accommodate the level of expressed interest. DVIC will
notify each presenter by mail or telephone of their assigned
presentation time. Persons who do not file an advance request for a
presentation, but desire to make an oral statement, may announce it
at the time of the comment period. These persons will be allocated
time as it permits.
For Further Information Contact: Anyone requiring information regarding
the ACCV should contact Kay Cook, DVIC, HSB, HRSA, Room 11C-26, 5600
Fishers Lane, Rockville, MD 20857; telephone (301) 443-6593 or e-mail:
kcook@hrsa.gov.
Dated: August 4, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-19109 Filed 8-10-09; 8:45 am]
BILLING CODE 4165-15-P