Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act, 39543-39544 [2010-16805]
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Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices
There will be 2,890 respondents for a
one-time survey total of 2,890 annual
responses. The hours per response is
estimated to be .33 hours. Thus the total
annual burden is estimated to be 953.7
hours. A 60 percent response rate is
expected.
Dated: July 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–16806 Filed 7–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0124]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requirements
Under the Comprehensive Smokeless
Tobacco Health Education Act of 1986,
as Amended by the Family Smoking
Prevention and Tobacco Control Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by August 9,
2010.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Requirements Under the
Comprehensive Smokeless Tobacco
Health Education Act of 1986, as
Amended by the Family Smoking
Prevention and Tobacco Control Act.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
ADDRESSES:
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15:17 Jul 08, 2010
Jkt 220001
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Requirements Under the
Comprehensive Smokeless Tobacco
Health Education Act of 1986, as
Amended by the Family Smoking
Prevention and Tobacco Control Act—
(OMB Control Number 0910–NEW)
On June 22, 2009, the President
signed the Tobacco Control Act (Public
Law 111–31) into law. The Smokeless
Tobacco Act (15 U.S.C. 4402), as
amended by section 204 of the Tobacco
Control Act, requires that
manufacturers, packagers, importers,
distributors, and retailers (in limited
circumstances) of smokeless tobacco
products include one of four specified
health warning label statements on
product packages and in
advertisements.1 The Smokeless
Tobacco Act, as amended, also requires
smokeless tobacco product
manufacturers, importers, distributors,
and certain retailers to submit a plan to
FDA specifying the method to rotate,
display, and distribute the specified
health warning label statements
required to appear in advertising and
packaging. FDA is required to review
each plan submitted and approve the
plan if it provides for rotation, display,
and distribution of warnings in
compliance with the requirements of the
Smokeless Tobacco Act. To the best of
FDA’s knowledge, all of the affected
companies have previously submitted
similar plans to the Federal Trade
Commission (FTC), which had authority
to implement the requirements of the
Smokeless Tobacco Act prior to the
Tobacco Control Act’s amendments.
However, because the requirements of
the Smokeless Tobacco Act have been
revised and because FDA now has
1 The warnings themselves disclose information
completely supplied by the Federal Government. As
such, the disclosure does not constitute a
‘‘collection of information’’ as it is defined in the
regulations implementing the PRA, nor, by
extension, do the financial resources expended in
relation to it constitute paperwork ‘‘burden.’’ (See 5
CFR 1320.3(c)(2).)
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39543
authority to implement the Smokeless
Tobacco Act, each affected company
will be required to submit a new plan
to FDA instead of FTC. The Tobacco
Control Act’s amendments to the
Smokeless Tobacco Act are effective on
June 22, 2010.
On August 7, 2007, FTC published a
30-day notice (72 FR 44138) announcing
an opportunity for public comment and
that the information collection would be
sent to OMB for review. Based on FTC’s
previous experience with the
submission of rotational plans and
FDA’s experience with smokeless
tobacco companies (e.g.,
correspondence associated with user
fees under section 919 of the Federal
Food, Drug, and Cosmetic Act, as
amended by the Tobacco Control Act),
FDA estimates that there are 14
companies affected by this information
collection. To account for the entry of
new smokeless tobacco companies who
may be affected by this information
collection, FDA is estimating the total
number of respondents to be 20.
When FTC originally implemented
the rotational plan requirements in
1986, the Smokeless Tobacco Council,
Inc., indicated that the six companies it
represented would require 700–800
hours in total (133 hours each) to
complete an initial rotational plan,
involving multiple brands, multiple
brand varieties, and multiple forms of
both packaging and advertising. When
FTC requested an extension of their
PRA clearance in 2007, FTC decreased
the estimate for submitting an initial
plan from 143 hours to 60 hours,
accounting for increased
computerization and improvements in
electronic communication over the
subsequent 20 years since the
Smokeless Tobacco Act was enacted.
FDA believes the estimate of 60 hours
to complete an initial rotational plan
continues to be reasonable. However,
because the requirements of the new
Smokeless Tobacco Act are unfamiliar
to industry, FDA is increasing the time
estimate for submitting initial plans to
100 hours.
In the Federal Register of March 16,
2010 (75 FR 12552), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received on this information collection.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\09JYN1.SGM
09JYN1
39544
Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Submission of rotational plans
for health warning label
statements
1 There
Annual Frequency
per Response
20
Total Annual
Responses
1
20
Total Hours
100
2,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 2, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Dated: July 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–16805 Filed 7–8–10; 8:45 am]
BILLING CODE 4160–01–S
[FR Doc. 2010–16741 Filed 7–8–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Institutes of Health
Disease, Disability, and Injury
Prevention and Control
Special Emphasis Panel (SEP):
Preparedness and Emergency Response
Learning Centers (PERLC) Panel,
Request for Applications (RFA) TP10–
1001, Initial Review
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the aforementioned meeting:
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Hours per
Response
Times and Dates: 8:30 a.m.–5 p.m., July 27,
2010 (Closed). 8:30 a.m.–5 p.m., July 28, 2010
(Closed). 8:30 a.m.–5 p.m., July 29, 2010
(Closed).
Place: The W Atlanta Hotel-Perimeter,
Perimeter Center West, Atlanta, Georgia
30346, Telephone: (770) 396–6800.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5,
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Section 10(d) of Public Law
92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Preparedness and Emergency
Response Learning Centers (PERLC) Panel,
RFA TP10–1001.’’
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Shoukat Qari, Senior Scientific Program
Official, Extramural Research Program, Office
of Public Health Preparedness and Response,
1600 Clifton Road, Mailstop D–44, Atlanta,
Georgia 30333, Telephone: (404) 639–7938,
E-mail: SQari@cdc.gov.
The Director, Management Analysis and
Services Office has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
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15:17 Jul 08, 2010
Jkt 220001
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Identification of Cancer Stem Cells
Description of Invention: Cancer stem
cells (CSC) are thought to be responsible
for cancer initiation, maintenance, and
therapeutic failure. A hallmark of stem
cells is self-renewal via asymmetric cell
division (ACD) into daughter stem-cells
and cells predestined for differentiation.
Demonstration of fundamental stemcell’s traits such as ACD in cancers is
lacking. Label retaining cells are thought
to be enriched for stem-like cells. Label
retaining cells are thought to be the
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results of either very slow cycling cells
and/or cells undergoing ACD. This
invention is directed to the
identification, isolation and purification
of cancer stem cells by detecting
asymmetrically dividing cells and/or
label retaining cells. Detection of
asymmetric cell division via nonrandom chromosomal cosegregation
(ACD–NRCC) in various human cancers
defines a unique and novel class of
universal cancer stem cells, and
potentially suggests a novel mechanism
of carcinogenesis. The isolation of CSC
might be used as a basis for a potential
new strategy in cancer therapeutics. The
invention also might have some
implications in genetics and
regenerative medicine.
Applications
• This invention may provide a novel
way to target various cancers for
treatment.
• This invention maybe also useful in
regenerative medicine, i.e. spinal cord
injury (regeneration of neurons),
Alzheimer (regeneration of neurons) and
Parkinson’s disease regeneration of
neurons).
Development Status: Pre-clinical stage
of development.
Market
• Cancer is the second leading cause
of death in the U.S. The National Cancer
Institute estimates the overall annual
costs for cancer in the U.S. at $107
billion; $37 billion for direct medical
costs, $11 billion for morbidity costs
(cost of lost productivity), and $59
billion for mortality costs.
• According to statistics gathered by
the National Institutes of Health, more
than 10,000 Americans experience
spinal cord injuries each year and more
than 200,000 are living with permanent
paralysis in their arms or legs due to
spinal cord injury.
• Parkinson’s disease affects some
four million patients worldwide.
Approximately 50,000 Americans are
diagnosed with Parkinson’s disease each
year. Alzheimer Disease is estimated to
affect 5.09 million patients by 2010.
Inventors: Itzhak Avital, Hong-Wu
Xin, Danielle M. Hari (NCI)
Publication: Manuscript submitted.
E:\FR\FM\09JYN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 131 (Friday, July 9, 2010)]
[Notices]
[Pages 39543-39544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16805]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0124]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements Under
the Comprehensive Smokeless Tobacco Health Education Act of 1986, as
Amended by the Family Smoking Prevention and Tobacco Control Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).
DATES: Fax written comments on the collection of information by August
9, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title ``Requirements Under the Comprehensive Smokeless Tobacco Health
Education Act of 1986, as Amended by the Family Smoking Prevention and
Tobacco Control Act.'' Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794, Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Requirements Under the Comprehensive Smokeless Tobacco Health Education
Act of 1986, as Amended by the Family Smoking Prevention and Tobacco
Control Act--(OMB Control Number 0910-NEW)
On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Smokeless Tobacco Act (15 U.S.C.
4402), as amended by section 204 of the Tobacco Control Act, requires
that manufacturers, packagers, importers, distributors, and retailers
(in limited circumstances) of smokeless tobacco products include one of
four specified health warning label statements on product packages and
in advertisements.\1\ The Smokeless Tobacco Act, as amended, also
requires smokeless tobacco product manufacturers, importers,
distributors, and certain retailers to submit a plan to FDA specifying
the method to rotate, display, and distribute the specified health
warning label statements required to appear in advertising and
packaging. FDA is required to review each plan submitted and approve
the plan if it provides for rotation, display, and distribution of
warnings in compliance with the requirements of the Smokeless Tobacco
Act. To the best of FDA's knowledge, all of the affected companies have
previously submitted similar plans to the Federal Trade Commission
(FTC), which had authority to implement the requirements of the
Smokeless Tobacco Act prior to the Tobacco Control Act's amendments.
However, because the requirements of the Smokeless Tobacco Act have
been revised and because FDA now has authority to implement the
Smokeless Tobacco Act, each affected company will be required to submit
a new plan to FDA instead of FTC. The Tobacco Control Act's amendments
to the Smokeless Tobacco Act are effective on June 22, 2010.
---------------------------------------------------------------------------
\1\ The warnings themselves disclose information completely
supplied by the Federal Government. As such, the disclosure does not
constitute a ``collection of information'' as it is defined in the
regulations implementing the PRA, nor, by extension, do the
financial resources expended in relation to it constitute paperwork
``burden.'' (See 5 CFR 1320.3(c)(2).)
---------------------------------------------------------------------------
On August 7, 2007, FTC published a 30-day notice (72 FR 44138)
announcing an opportunity for public comment and that the information
collection would be sent to OMB for review. Based on FTC's previous
experience with the submission of rotational plans and FDA's experience
with smokeless tobacco companies (e.g., correspondence associated with
user fees under section 919 of the Federal Food, Drug, and Cosmetic
Act, as amended by the Tobacco Control Act), FDA estimates that there
are 14 companies affected by this information collection. To account
for the entry of new smokeless tobacco companies who may be affected by
this information collection, FDA is estimating the total number of
respondents to be 20.
When FTC originally implemented the rotational plan requirements in
1986, the Smokeless Tobacco Council, Inc., indicated that the six
companies it represented would require 700-800 hours in total (133
hours each) to complete an initial rotational plan, involving multiple
brands, multiple brand varieties, and multiple forms of both packaging
and advertising. When FTC requested an extension of their PRA clearance
in 2007, FTC decreased the estimate for submitting an initial plan from
143 hours to 60 hours, accounting for increased computerization and
improvements in electronic communication over the subsequent 20 years
since the Smokeless Tobacco Act was enacted. FDA believes the estimate
of 60 hours to complete an initial rotational plan continues to be
reasonable. However, because the requirements of the new Smokeless
Tobacco Act are unfamiliar to industry, FDA is increasing the time
estimate for submitting initial plans to 100 hours.
In the Federal Register of March 16, 2010 (75 FR 12552), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on this
information collection.
FDA estimates the burden of this collection of information as
follows:
[[Page 39544]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of rotational plans for health warning 20 1 20 100 2,000
label statements
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16805 Filed 7-8-10; 8:45 am]
BILLING CODE 4160-01-S
