Risk Communication Advisory Committee; Notice of Meeting, 48759-48760 [E9-23001]
Download as PDF
<![CDATA[
Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices
Dated: September 17, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23126 Filed 9–23–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the NIH Scientific
Review Board, September 24, 2009,
8 a.m. to 3 p.m., National Institutes of
Health, Building 60, Chapel and Lecture
Hall, 9000 Rockville Pike, Bethesda, MD
20892 which was published in the
Federal Register on September 14, 2009,
74 FR 46998.
The notice is being amended to cancel
the September 24, 2009, Deliberating
Organizational Changes and
Effectiveness Working Group forum.
Please see the Scientific Management
Review Board Web site for the schedule
of upcoming meetings at: https://
smrb.od.nih.qov. For further
information contact Dr. Lyric Jorgenson,
Office of Science Policy, Office of the
Director, National Institutes of Health,
Building 1, Room 218, MSC 0166, 9000
Rockville Pike, Bethesda, MD 20892.
Dated: September 16, 2009.
Amy Patterson,
Director, Office of Biotechnology Activities.
[FR Doc. E9–23032 Filed 9–23–09; 8:45 am]
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group; Cellular
Aspects of Diabetes and Obesity Study
Section.
Date: October 5–6, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Ann A. Jerkins, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6154,
MSC 7892, Bethesda, MD 20892, 301–435–
4514, jerkinsa@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: September 16, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23031 Filed 9–23–09; 8:45 am]
BILLING CODE 4140–01–M
National Institutes of Health
srobinson on DSKHWCL6B1PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
VerDate Nov<24>2008
16:27 Sep 23, 2009
Jkt 217001
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Michael Micklin, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3136,
MSC 7759, Bethesda, MD 20892, (301) 435–
1258, micklinm@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: September 16, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23028 Filed 9–23–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Risk Communication Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
48759
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel. Member
Conflict: Interventions for Substance Abuse.
Date: September 23, 2009.
Time: 2 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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.
Date and Time: The meeting will be held
on November 12, 2009, from 8 a.m. to 5 p.m.
and November 13, 2009, from 8 a.m. to 2 p.m.
Location: The Hilton Hotel, 8727 Colesville
Rd., Silver Spring, MD 20910.
Contact Person: Lee L. Zwanziger, Office of
the Commissioner, Office of Policy, Planning
and Preparedness, Office of Planning, Food
and Drug Administration, 5600 Fishers Lane,
rm. 14–90, Rockville, MD 20857, 301–827–
2895, FAX: 301–827–4050, e-mail:
RCAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington, DC
area), code 8732112560. 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
E:\FR\FM\24SEN1.SGM
24SEN1
srobinson on DSKHWCL6B1PROD with NOTICES
48760
Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices
appropriate advisory committee hot line/
phone line to learn about possible
modifications before coming to the meeting.
Agenda: On November 12 and 13, 2009,
the Committee will discuss strategies and
programs designed to communicate with the
public about the risks and benefits of FDAregulated products so as to facilitate optimal
use of these products. For more specific
agenda topics, please visit the following Web
site and scroll down to the appropriate
advisory committee link (https://
www.fda.gov/AdvisoryCommittees/Calendar/
default.htm), or call the FDA Advisory
Committee Information Line as detailed
under ‘‘Contact Person’’. FDA intends to
provide specific agenda topics at both these
locations no later than 15 days before the
meeting.
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
November 4, 2009. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. on
November 12, 2009, and between
approximately 10:30 a.m. and 11:30 a.m. on
November 13, 2009. 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 4, 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 November
5, 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 Lee
Zwanziger at least 7 days in advance of the
meeting.
VerDate Nov<24>2008
16:27 Sep 23, 2009
Jkt 217001
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: September 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23001 Filed 9–23–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel. ‘‘NIAID Science Education
Awards.’’
Date: October 5, 2009.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge 6700, 6700B Rockledge Drive,
Bethesda, MD 20817 (Telephone Conference
Call).
Contact Person: Jay Bruce Sundstrom, PhD,
Scientific Review Official, Scientific Review
Program, DEA/NIAID/NIH/DHHS, Room
2217, 6700B Rockledge Drvie, MSC–7616,
Bethesda, MD 20892–7616, (301) 496–2550,
sundstromj@niaid.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Frm 00052
Fmt 4703
Sfmt 4703
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0444]
Schmid Laboratories, Inc. et al.;
Proposal To Withdraw Approval of Five
New Drug Applications; Opportunity
for a Hearing
AGENCY:
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
PO 00000
Dated: September 18, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23121 Filed 9–23–09; 8:45 am]
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity to request a hearing on the
agency’s proposal to withdraw approval
of five new drug applications (NDAs)
from multiple sponsors. The basis for
the proposal is that the sponsors have
repeatedly failed to file required annual
reports for these applications.
DATES: Submit written requests for a
hearing by October 26, 2009; submit
data and information in support of the
hearing request by November 23, 2009.
ADDRESSES: Requests for a hearing,
supporting data, and other comments
are to be identified with Docket No.
FDA–2009–N–0444 and submitted to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
holders of approved applications to
market new drugs for human use are
required to submit annual reports to
FDA concerning each of their approved
applications in accordance with
§ 314.81 (21 CFR 314.81). The holders of
the approved applications listed in table
1 of this document have failed to submit
the required annual reports and have
not responded to the agency’s request by
certified mail for submission of the
reports.
E:\FR\FM\24SEN1.SGM
24SEN1
]]>Agencies
[Federal Register Volume 74, Number 184 (Thursday, September 24, 2009)]
[Notices]
[Pages 48759-48760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23001]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Risk Communication 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: Risk Communication 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 12, 2009,
from 8 a.m. to 5 p.m. and November 13, 2009, from 8 a.m. to 2 p.m.
Location: The Hilton Hotel, 8727 Colesville Rd., Silver Spring,
MD 20910.
Contact Person: Lee L. Zwanziger, Office of the Commissioner,
Office of Policy, Planning and Preparedness, Office of Planning,
Food and Drug Administration, 5600 Fishers Lane, rm. 14-90,
Rockville, MD 20857, 301-827-2895, FAX: 301-827-4050, e-mail:
RCAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 8732112560.
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
[[Page 48760]]
appropriate advisory committee hot line/phone line to learn about
possible modifications before coming to the meeting.
Agenda: On November 12 and 13, 2009, the Committee will discuss
strategies and programs designed to communicate with the public
about the risks and benefits of FDA-regulated products so as to
facilitate optimal use of these products. For more specific agenda
topics, please visit the following Web site and scroll down to the
appropriate advisory committee link (https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm), or call the FDA Advisory
Committee Information Line as detailed under ``Contact Person''. FDA
intends to provide specific agenda topics at both these locations no
later than 15 days before the meeting.
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
November 4, 2009. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. on November 12,
2009, and between approximately 10:30 a.m. and 11:30 a.m. on
November 13, 2009. 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 4, 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
November 5, 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 Lee Zwanziger 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: September 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23001 Filed 9-23-09; 8:45 am]
BILLING CODE 4160-01-S
