Tobacco Products Scientific Advisory Committee; Notice of Meeting, 47308-47309 [2010-19283]
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Federal Register / Vol. 75, No. 150 / Thursday, August 5, 2010 / Notices
evolving information, novel
technologies, and new scientific
methods—into its decision making,
while also maintaining as much
predictability as practical.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
C. Preliminary Reports
FDA is making available for public
comment a two-volume set of
documents entitled ‘‘Center for Devices
and Radiological Health Preliminary
Internal Evaluations.’’ Volume I is
entitled ‘‘510(k) Working Group
Preliminary Report and
Recommendations.’’ This preliminary
report is intended to communicate
preliminary findings and
recommendations regarding the 510(k)
program and actions CDRH might take
to address identified areas of concern.
Volume II is entitled ‘‘Task Force on the
Utilization of Science in Regulatory
Decision Making Preliminary Report
and Recommendations.’’ This
preliminary report is intended to
communicate preliminary findings and
recommendations regarding the
incorporation of new scientific
information into CDRH’s decision
making and actions CDRH might take to
address identified areas of concern.
Interested persons are invited to
comment on either or both of these
preliminary reports. CDRH will consider
comments received prior to finalizing
the two reports and determining which,
if any, recommendations to implement
in their current or a modified form.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
mstockstill on DSKH9S0YB1PROD with NOTICES
III. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.regulations.gov or https://
www.fda.gov/AboutFDA/CentersOffices/
CDRH/CDRHReports/default.htm (select
appropriate option from the menu).
Dated: July 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19339 Filed 8–4–10; 8:45 am]
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Tobacco Products Scientific 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: Tobacco
Products Scientific 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 August 30, 2010, from 8:30 a.m.
to 12 noon.
Location: Gaithersburg Marriott
Washingtonian Center, 9751
Washingtonian Blvd., Gaithersburg, MD.
The hotel telephone number is 301–
590–0044.
Contact Person: Cristi Stark, Center
for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373
(choose option 4), e-mail:
TPSAC@fda.hhs.gov or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
8732110002. 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 August 30, 2010, the
committee will receive a report from the
Tobacco Product Constituents
Subcommittee and discuss a proposed
initial list of harmful or potentially
harmful constituents, the rationale for
inclusion of each constituent,
established analytical methods as well
as the ancillary methods and
normalization standards for the
identified constituents.
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
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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 August 23, 2010.
Oral presentations from the public will
be scheduled between approximately 10
a.m. and 11 a.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 August 13, 2010. 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 August 16, 2010.
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 Cristi Stark
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).
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Federal Register / Vol. 75, No. 150 / Thursday, August 5, 2010 / Notices
Dated: August 2, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–19283 Filed 8–4–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Psychopharmacologic Drugs 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:
Psychopharmacologic Drugs 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 September 16, 2010, from 8:30
a.m. to 5 p.m.
Location: FDA White Oak Campus,
the Great Room, 10903 New Hampshire
Ave., Bldg. 31, White Oak Conference
Center (rm. 1503), Silver Spring, MD
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You’’ tab,
click on ‘‘White Oak Conference Center
Parking and Transportation Information
for FDA Advisory Committee Meetings.’’
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, e-mail:
yvette.waples@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544. 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
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17:52 Aug 04, 2010
Jkt 220001
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
the available safety and efficacy data for
supplemental new drug application
(sNDA) 21–897/015, VIVITROL
(naltrexone for extended-release
injectable suspension), sponsored by
Alkermes, Inc., for the treatment of
opioid dependence.
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 1, 2010.
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 August 24, 2010. 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 August 25, 2010.
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 Yvette
Waples at least 7 days in advance of the
meeting.
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47309
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: July 28, 2010.
Thinh Nguyen,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–19161 Filed 8–4–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; 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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Ancillary Clinical
Studies Review Meeting.
Date: September 1, 2010.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: John F. Connaughton, PhD,
Chief, Chartered Committees Section, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 753, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452. (301)
594–7797.
connaughtonj@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
E:\FR\FM\05AUN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 150 (Thursday, August 5, 2010)]
[Notices]
[Pages 47308-47309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19283]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Tobacco Products Scientific 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: Tobacco Products Scientific 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 August 30, 2010, from
8:30 a.m. to 12 noon.
Location: Gaithersburg Marriott Washingtonian Center, 9751
Washingtonian Blvd., Gaithersburg, MD. The hotel telephone number is
301-590-0044.
Contact Person: Cristi Stark, Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-
287-1373 (choose option 4), e-mail: TPSAC@fda.hhs.gov or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 8732110002. 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 August 30, 2010, the committee will receive a report
from the Tobacco Product Constituents Subcommittee and discuss a
proposed initial list of harmful or potentially harmful constituents,
the rationale for inclusion of each constituent, established analytical
methods as well as the ancillary methods and normalization standards
for the identified constituents.
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
August 23, 2010. Oral presentations from the public will be scheduled
between approximately 10 a.m. and 11 a.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 August 13, 2010. 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 August
16, 2010.
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 Cristi Stark 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).
[[Page 47309]]
Dated: August 2, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-19283 Filed 8-4-10; 8:45 am]
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