Menthol Report Subcommittee of the Tobacco Products Scientific Advisory Committee; Notice of Meeting, 2397-2398 [2011-635]
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2397
Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Annual
frequency per
recordkeeping
Number of
recordkeepers
21 CFR section
1.337, 1.345, and 1.352 (Records maintenance) ............
1.337, 1.345, and 1.352 (Learning for new firms) ...........
379,493
18,975
1
1
Total annual
records
379,493
18,975
Total ..........................................................................
1 There
Dated: January 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–592 Filed 1–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
srobinson on DSKHWCL6B1PROD with NOTICES
[Docket No. FDA–2011–N–0002]
Menthol Report Subcommittee of the
Tobacco Products Scientific Advisory
Committee; Notice of Meeting
Food and Drug Administration,
HHS.
ACTION:
13.228
4.790
Total hours
5,020,000
90,890
5,110,890
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on FDA’s
estimate of the number of facilities
affected by the final rule entitled
‘‘Establishment and Maintenance of
Records Under the Public Health
Security and Bioterrorism Preparedness
and Response Act of 2002,’’ published in
the Federal Register of December 9,
2004 (69 FR 71562 at 71630). With
regard to records maintenance, FDA
estimates that approximately 379,493
facilities will spend 13.228 hours
collecting, recording, and checking for
accuracy the limited amount of
additional information required by the
regulations, for a total of 5,020,000
hours annually. In addition, FDA
estimates that new firms entering the
affected businesses will incur a burden
from learning the regulatory
requirements and understanding the
records required for compliance. In this
regard, the Agency estimates the
number of new firms entering the
affected businesses to be 5 percent (5%)
of 379,493, or 18,975 firms. Thus, FDA
estimates that approximately 18,975
facilities will spend 4.790 hours
learning about the recordkeeping and
records access requirements, for a total
of 90,890 hours annually. Therefore, the
total annual recordkeeping burden is
estimated to be 5,110,890 hours.
AGENCY:
Hours per
record
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
VerDate Mar<15>2010
16:15 Jan 12, 2011
Jkt 223001
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Menthol Report
Subcommittee of the 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 February 11, 2011, from 9 a.m.
to 5 p.m.
Location: Center for Tobacco
Products, 9200 Corporate Blvd,
Rockville, MD, 20850. The telephone
number is 1–877–287–1373.
Contact Person: Caryn Cohen, Office
of Science, Center for Tobacco Products,
Food and Drug Administration, 9200
Corporate Blvd, Rockville, MD 20850,
1–877–287–1373 (choose Option 4), email: TPSAC@fda.hhs.gov or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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 February 11, 2011, the
subcommittee will receive presentations
and discuss the timelines and structure
of the Tobacco Products Scientific
Advisory Committee’s required report to
the Secretary of Health and Human
Services regarding the impact of use of
menthol in cigarettes on the public
health.
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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
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 January 28, 2011.
Oral presentations from the public will
be scheduled between approximately 11
a.m. and 12 noon on February 11, 2011.
Those individuals interested in making
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 January 20, 2011. 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
January 21, 2011.
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 Caryn Cohen
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/
E:\FR\FM\13JAN1.SGM
13JAN1
2398
Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices
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: January 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–635 Filed 1–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Tobacco Products Scientific Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed 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 February 10, 2011, from 8 a.m.
until 5 p.m.
Location: Center for Tobacco
Products, 9200 Corporate Blvd.,
Rockville, MD 20850. The phone
number is 1–877–287–1373.
Contact Person: Caryn Cohen, Office
of Science, Center for Tobacco Products,
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
1–877–287–1373 (choose Option 4), email: TPSAC@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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.
VerDate Mar<15>2010
16:15 Jan 12, 2011
Jkt 223001
Agenda: On February 10, 2011, the
Committee will continue to do the
following: (1) Receive updates from the
Menthol Report Subcommittee and (2)
receive and discuss presentations
regarding the data requested by the
Committee at the March 30 through 31,
2010, meeting of the Tobacco Products
Scientific Advisory Committee.
FDA intends to make redacted
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: On February 10, 2011,
from 1 p.m. to 5 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 January 27, 2011.
Oral presentations from the public will
be scheduled between approximately 3
p.m. and 4 p.m. on February 10, 2011.
Those individuals interested in making
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 January 19, 2011. 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
January 20, 2011.
Closed Committee Deliberations: On
January 10, 2011, from 9 a.m. to 12
noon, the meeting will be closed to
permit discussion and review of trade
secret and/or confidential commercial
information (5 U.S.C. 552b(c)(4)). This
portion of the meeting must be closed
because the Committee will be
discussing trade secret and/or
confidential data provided by the
Federal Trade Commission and the
tobacco industry.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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 Caryn Cohen
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: January 10, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–634 Filed 1–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; California Health
Interview Survey Cancer Control
Module (CHIS–CCM) 2011 (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on November 15,
2010 (75 FR 69681) and allowed 60 days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institutes of Health may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: California
Health Interview Survey Cancer Control
Module (CHIS–CCM) 2011. Type of
SUMMARY:
E:\FR\FM\13JAN1.SGM
13JAN1
]]>Agencies
[Federal Register Volume 76, Number 9 (Thursday, January 13, 2011)]
[Notices]
[Pages 2397-2398]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-635]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Menthol Report Subcommittee of the 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: Menthol Report Subcommittee of the 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 February 11, 2011, from
9 a.m. to 5 p.m.
Location: Center for Tobacco Products, 9200 Corporate Blvd,
Rockville, MD, 20850. The telephone number is 1-877-287-1373.
Contact Person: Caryn Cohen, Office of Science, 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), and follow the prompts to the desired
center or product area. 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 February 11, 2011, the subcommittee will receive
presentations and discuss the timelines and structure of the Tobacco
Products Scientific Advisory Committee's required report to the
Secretary of Health and Human Services regarding the impact of use of
menthol in cigarettes on the public health.
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
January 28, 2011. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 noon on February 11, 2011. Those
individuals interested in making 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
January 20, 2011. 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 January 21,
2011.
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 Caryn Cohen 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/
[[Page 2398]]
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: January 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-635 Filed 1-12-11; 8:45 am]
BILLING CODE 4160-01-P
