Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products; Correction, 57568-57569 [2012-22920]
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Federal Register / Vol. 77, No. 181 / Tuesday, September 18, 2012 / Notices
agreed to international standards on
reporting public health incidents of
concern under IHR (2005). Additionally,
a majority of States Parties have also
agreed to specific work-frames for
pathogens such as smallpox under the
Biological Weapons Convention.
Since May 1999, when the 52nd
World Health Assembly (WHA) resolved
to postpone the destruction of the
Variola virus to allow for essential
research (WHA 52.10), WHO has been
charged with convening a group of
experts to advise on the need for
continuing such research, to review
proposals for research involving viable
Variola virus, to review the progress of
such research, and to report to the WHA
each year. The need to support the
activities described in this project has
not changed. In fact, WHO Member
States continue to exert pressure for the
WHO Secretariat to carry out this work.
The WHO Advisory Committee on
Variola Virus Research (ACVVR) was
established in 1999 to determine what
essential research, if any, must be
carried out with live Variola virus. The
ACVVR monitored the research progress
in order to reach global consensus on
the timing for the destruction of existing
Variola virus stocks. In 2007, the WHA
requested the ACVVR undertake a
thorough review of the approved
research program with a report
presented in 2010. The results were
presented at the 64th WHA meeting in
May of 2011. The ACVVR continues to
serve a critically important function for
global public health, and to oversee
research requested specifically by the
U.S. to complete its national strategic
goals. This includes the development of
new antiviral agents, safer vaccines, and
better diagnostics, thus strengthening
our national security.
Additional Information: The agency
program contact is Richard J. Hatchett,
MD, who can be contacted by phone at
(202) 260–0150 or via email at
Richard.Hatchett@hhs.gov.
Dated: September 12, 2012.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0386]
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of May 3, 2012 (77 FR 26281).
The document announced an
opportunity for public comment on the
proposed extension of an existing
collection of information by the Agency
pertaining to registration and product
listing for owners and operators of
domestic tobacco product
establishments and to listing of
ingredients in tobacco products under
the Family Smoking Prevention and
Tobacco Control Act. The document
published with incorrect FDA form
numbers. This document corrects those
errors.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2012–10645 appearing on page 26281 in
the Federal Register of Thursday, May
3, 2012, the following corrections are
made:
1. On page 26282, in the third
column, in the first full paragraph, the
fifth sentence ‘‘FDA also developed
paper forms (Form FDA 3742—
Registration and Listing for Owners and
Operators of Domestic Tobacco Product
Establishments and Form FDA 3743—
Listing of Ingredients in Tobacco
Products) as an alternative submission
tool.’’ is corrected to read ‘‘FDA also
developed paper forms (Form FDA
3741—Registration and Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Form FDA 3742—Listing of Ingredients
in Tobacco Products) as an alternative
submission tool.’’
2. On page 26283, in the table, ‘‘Form
FDA 3742’’ is corrected to read ‘‘Form
FDA 3741’’ and ‘‘Form FDA 3743’’ is
corrected to read ‘‘Form FDA 3742’’.
SUMMARY:
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Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration and
Product Listing for Owners and
Operators of Domestic Tobacco
Product Establishments and Listing of
Ingredients in Tobacco Products;
Correction
AGENCY:
Dated: September 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0386]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration and
Product Listing for Owners and
Operators of Domestic Tobacco
Product Establishments and Listing of
Ingredients in Tobacco Products;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of August 3, 2012 (77 FR
46441). The document announced that a
proposed collection of information had
been submitted to the Office of
Management and Budget for review and
clearance under the Paperwork
Reduction Act of 1995. The document
published with incorrect FDA form
numbers. This document corrects those
errors.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2012–18975 appearing on page 46441 in
the Federal Register of Friday, August
3, 2012, the following corrections are
made:
1. On page 46442, in the third
column, in the first full paragraph, the
fifth sentence ‘‘FDA also developed
paper forms (Form FDA 3742—
Registration and Listing for Owners and
Operators of Domestic Tobacco Product
Establishments and Form FDA 3743—
Listing of Ingredients in Tobacco
Products) as an alternative submission
tool.’’ is corrected to read ‘‘FDA also
developed paper forms (Form FDA
3741—Registration and Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Form FDA 3742—Listing of Ingredients
in Tobacco Products) as an alternative
submission tool.’’
SUMMARY:
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Federal Register / Vol. 77, No. 181 / Tuesday, September 18, 2012 / Notices
2. On page 46442, in table 1, ‘‘Form
FDA 3742’’ is corrected to read ‘‘Form
FDA 3741’’ and ‘‘Form FDA 3743’’ is
corrected to read ‘‘Form FDA 3742’’.
Dated: September 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–22920 Filed 9–17–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Science Advisory Board to the
National Center for Toxicological
Research; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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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: Science
Advisory Board (SAB) to the National
Center for Toxicological Research
(NCTR).
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 October 23, 2012, from 8:45
a.m. to 5 p.m. and on October 24, 2012,
from 8 a.m. to 12 p.m.
Location: NCTR SAB Conference
Room B–12, 3900 NCTR Rd., Jefferson,
AR 72079.
Contact Person For More Information:
Margaret Miller, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 2208, Silver Spring,
MD 20993–0002, 301–796–8890, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On October 23, 2012, the
NCTR Director will welcome the
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participants and provide a Center-wide
update on scientific initiatives and
accomplishments during the past year.
The SAB will then briefly review an
update of research activities of the
Division of Neurotoxicology. The SAB
will be presented with the NanoCore
Subcommittee report, and will provide
a response to that report. The SAB will
review and update of the research
activities of the Division of Genetic and
Molecular Toxicology.
Following the public session, the SAB
will hear an update from the Office of
Science Coordination, followed by a
report from the National Toxicology
Program on current and future
collaboration.
The Center for Biological Evaluation
and Research, Center for Drug
Evaluation and Research, Center for
Devices and Radiological Health, Center
for Veterinary Medicine, Center for
Tobacco Products, and the Center for
Food Safety and Applied Nutrition will
each briefly discuss their center-specific
research strategic needs.
On October 24, 2012, the Director of
the Center for Food Safety and Applied
Nutrition will update the SAB on their
research needs, and discuss
opportunities for collaboration to help
address these needs.
The SAB will discuss an overview of
research activities from the NCTR
Division of Bioinformatics and
Computational Biology and the Division
of Systems Biology. The SAB will also
receive and update from the
subcommittee on Immunotoxicology.
Following an open discussion of all
the information presented, the open
session of the meeting will close so that
SAB members can discuss personnel
issues at NCTR.
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 meeting
link.
Procedure: On October 23, 2012, from
8:45 a.m. to 12 p.m. and from 2 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
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57569
October 16, 2012. Oral presentations
from the public will be scheduled
between approximately 12 p.m. to 2
p.m. 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 October 9, 2012. 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 October 10, 2012.
Closed Committee Deliberations: On
October 24, 2012, from 12 p.m. to 2
p.m., the meeting will be closed to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c) (6)). This portion of the meeting
will be closed to permit discussion of
information concerning individuals
associated with the research programs at
NCTR.
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 Margaret
Miller 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 12, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
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Agencies
[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Notices]
[Pages 57568-57569]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22920]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0386]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration and
Product Listing for Owners and Operators of Domestic Tobacco Product
Establishments and Listing of Ingredients in Tobacco Products;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of August 3, 2012 (77 FR 46441).
The document announced that a proposed collection of information had
been submitted to the Office of Management and Budget for review and
clearance under the Paperwork Reduction Act of 1995. The document
published with incorrect FDA form numbers. This document corrects those
errors.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc. 2012-18975 appearing on page
46441 in the Federal Register of Friday, August 3, 2012, the following
corrections are made:
1. On page 46442, in the third column, in the first full paragraph,
the fifth sentence ``FDA also developed paper forms (Form FDA 3742--
Registration and Listing for Owners and Operators of Domestic Tobacco
Product Establishments and Form FDA 3743--Listing of Ingredients in
Tobacco Products) as an alternative submission tool.'' is corrected to
read ``FDA also developed paper forms (Form FDA 3741--Registration and
Listing for Owners and Operators of Domestic Tobacco Product
Establishments and Form FDA 3742--Listing of Ingredients in Tobacco
Products) as an alternative submission tool.''
[[Page 57569]]
2. On page 46442, in table 1, ``Form FDA 3742'' is corrected to
read ``Form FDA 3741'' and ``Form FDA 3743'' is corrected to read
``Form FDA 3742''.
Dated: September 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22920 Filed 9-17-12; 8:45 am]
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