Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Graphic Cigarette Warning Labels, 7604-7606 [2010-3320]
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7604
Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices
grants at different times, we have
assumed that new cohorts will replace
previous cohorts. Therefore, the number
of grantees in each year is assumed to
be constant.
TABLE—ESTIMATES OF ANNUALIZED HOUR BURDEN
Number of
respondents
Measure name
Number of
responses/
respondent
Hours/
response
Response
burden
(in hours)
State/Tribal Cross-Site Evaluation Instruments
Prevention Strategies Inventory—State Tribal (PSI–ST) ..............................
Training Exit Survey State/Tribal (TES–ST) ..................................................
Training Utilization and Penetration Survey (TUP–S) ...................................
Training Utilization and Penetration Interview (TUP–I) .................................
Referral Network Survey (RNS) ....................................................................
Early Identification, Referral and Follow Up Analysis (EIRF) ........................
Early Identification, Referral and Follow Up Aggregate Screening Form
(EIRF–S) ....................................................................................................
Training Exit Survey Cover Page State/Tribal (TES–CP–ST) ......................
48
94,848
2,000
100
1,024
48
4
1
1
1
1
4
0.75
0.17
0.25
0.67
0.67
1
144
16,125
500
67
687
192
48
48
4
4
0.33
0.33
64
64
38
23,712
4
1
0.75
0.17
114
4,032
7,600
1
0.42
3,192
1,900
38
76
38
38
38
38
1
1
1
1
1
4
4
0.25
0.75
0.75
0.75
0.75
0.33
0.33
475
29
57
29
29
51
51
1.5
1.5
1.5
1
1
1
1
1
1
1
324
108
54
8
4
8
8
8
12
8
Campus Cross-Site Evaluation Instruments
Prevention Strategies Inventory—Campus (PSI–C) ......................................
Training Exit Survey Campus (TES–C) .........................................................
Suicide Prevention Exposure, Awareness and Knowledge Survey—Student Version (SPEAKS–S) .........................................................................
Suicide Prevention Exposure, Awareness and Knowledge Survey—Faculty/Staff (SPEAKS–FS) .............................................................................
Campus Infrastructure Interview (CIFI) for Student ......................................
Campus Infrastructure Interview (CIFI) for Faculty .......................................
Campus Infrastructure Interview (CIFI) for Administrator ..............................
Campus Infrastructure Interview (CIFI) for Counselor ..................................
Training Exit Survey Cover Page Campus (TES–CP–C) .............................
MIS Data Abstraction .....................................................................................
Campus Case Studies Evaluation Instruments
Focus Group—Student Version .....................................................................
Focus Group—Faculty Version .....................................................................
Focus Group—Staff Version ..........................................................................
Interview—Student Leader Version ...............................................................
Interview—Case Finder Version ....................................................................
Interview—Faculty Version ............................................................................
Interview—Campus Police Version ...............................................................
Interview—Counseling Staff Version .............................................................
Interview—Prevention Staff Version ..............................................................
Interview—Administrator Version ..................................................................
216
72
36
8
4
8
8
8
12
8
1
1
1
1
1
1
1
1
1
1
Total ........................................................................................................
........................
132,060
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857 and e-mail a copy
to summer.king@samhsa.hhs.gov.
Written comments should be received
within 60 days of this notice.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
Dated: February 5, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–3326 Filed 2–19–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0079]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Graphic Cigarette Warning
Labels
AGENCY:
BILLING CODE 4162–20–P
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
VerDate Nov<24>2008
15:26 Feb 19, 2010
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..........................
26,444
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the Experimental Study of Graphic
Cigarette Warning Labels that is being
conducted in support of the graphic
label statement provision of the Family
Smoking Prevention and Tobacco
Control Act (the Tobacco Control Act).
DATES: Submit written or electronic
comments on the collection of
information by April 23, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
E:\FR\FM\22FEN1.SGM
22FEN1
Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
JonnaLynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Experimental Study of Graphic
Cigarette Warning Labels
Tobacco products are responsible for
more than 440,000 deaths each year.
The Centers for Disease Control and
Prevention report that approximately 46
million U.S. adults smoke cigarettes in
the United States, even though this
behavior will result in death or
disability for half of all regular users.
Paralleling this enormous health burden
is the economic burden of tobacco use,
which is estimated to total $193 billion
annually in medical expenditures and
lost productivity. Curbing the
significant adverse consequences of
tobacco use is one of the most important
public health goals of our time. One way
to do this is through health warnings
that describe and graphically depict the
harm caused by cigarette use.
On June 22, 2009, the President
signed the Tobacco Control Act (Public
Law 111–31) into law. The Tobacco
Control Act granted FDA important new
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect the public health
generally and to reduce tobacco use by
minors. Section 201 of the Tobacco
Control Act, which amends section 4 of
the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333),
requires FDA to issue ‘‘regulations that
require color graphics depicting the
negative health consequences of
smoking to accompany the label
statements specified in subsection
(a)(1).’’ FDA conducts research relating
to tobacco products under its statutory
authority in section 1103(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act,
as amended by the Tobacco Control Act,
to conduct research ‘‘relating to foods,
drugs, cosmetics, devices, and tobacco
7605
products in carrying out the act.’’ The
study proposed here is an effort by FDA
to collect data concerning graphic
warnings on cigarette packages and their
impact on consumer perceptions,
attitudes, and behavior with respect to
smoking.
The study, the Experimental Study of
Graphic Cigarette Warning Labels, is a
voluntary experimental survey of
consumers. The purpose of the study is
to assess the effectiveness of various
graphic warnings on cigarette packs for
achieving three communication goals:
(1) Conveying information about various
health risks of smoking, (2) encouraging
cessation of smoking among current
smokers, and (3) discouraging initiation
of smoking among youth and former
smokers. The study will collect data
from various groups of consumers,
including current smokers aged 13 years
and older, former smokers aged 13 years
and older, and non-smokers aged
between 13 and 25 years who may be
susceptible to initiation of smoking. The
study goals are to: (1) Measure
consumer attitudes, beliefs, and
intended behaviors related to cigarette
smoking in response to graphic warning
labels; (2) determine whether consumer
responses to graphic warning labels
differ across various groups based on
smoking status, age, or other
demographic variables; and (3) evaluate
the relative effectiveness of various
graphic images associated with each of
the nine warning statements specified in
the Tobacco Control Act for achieving
each of the communication goals. The
information collected from the study is
necessary to inform the agency’s efforts
to implement the mandatory graphic
warnings required by the Tobacco
Control Act.
The experimental study data will be
collected from participants of an
Internet panel of approximately 43,000
people. Participation in the
experimental study is voluntary.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Portion of Study
No. of
Respondents
cprice-sewell on DSK2BSOYB1PROD with NOTICES
Pre-test
Annual Frequency
per Response
Hours per
Response
60
60
1
15,000
5,400
1
5,400
1
Experimental Survey
1
15,000
Screener
15,460
Total
1 There
Total Annual
Responses
0.5
0.016
0.5
15:26 Feb 19, 2010
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30
240
2,700
2,970
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Nov<24>2008
Total Hours
22FEN1
7606
Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here. Sixty panel members
will take part in a pre-test of the study,
estimated to last 30 minutes (0.5 hours),
for a total of 30 hours. Approximately
15,000 respondents will complete a
screener to determine eligibility for
participation in the study, estimated to
take 1 minute (0.016 hours), for a total
of 125 hours. Fifty-four hundred (5,400)
respondents will complete the full
study, estimated to last 30 minutes (0.5
hours), for a total of 2,700 hours. The
total estimated burden is 2,970 hours.
[FR Doc. 2010–3148 Filed 2–19–10; 8:45 am]
[FR Doc. 2010–3320 Filed 2–19–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC): Notice of Charter
Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
Advisory Committee to the Director,
Centers for Disease Control and
Prevention of the Department of Health
and Human Services, has been renewed
for a 2-year period extending through
February 1, 2012.
Contact Person for More Information:
Anne C. Haddix, PhD, Designated
Federal Officer, ACD, CDC, 1600 Clifton
Road, NE., M/S D14, Atlanta, Georgia
30333. Telephone 404–639–0663.
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 the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Jkt 220001
[Docket No. FDA–1996–N–0006] (formerly
Docket No. 1996N–0277)
Safety and Efficacy Review for
Additional Ingredients in Over-theCounter Drug Products for Human
Use; Request for Environmental
Impact Data and Information
AGENCY:
Food and Drug Administration,
HHS.
Disease, Disability, and Injury
Prevention and Control
ACTION: Request for data and
information.
SUMMARY: We (Food and Drug
Administration (FDA)) are requesting
data and information regarding the
potential environmental impact of
amending over-the-counter (OTC) drug
monographs to include certain active
ingredients not previously marketed in
the United States or marketed in the
United States under approved
applications after the OTC drug review
began in 1972. Thirteen active
ingredients have been found eligible for
potential inclusion in OTC drug
monographs based on time and extent
applications (TEAs). We are currently
evaluating the safety and effectiveness
of these ingredients.
DATES: Submit data, information, and
general comments by May 24, 2010.
ADDRESSES: Submit electronic or written
data, information, and general
comments in response to this document.
Submit electronic comments to https://
regulations.gov. Submit written
comments to the Division of Dockets
Management HFA–305), 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Michael L. Koenig, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5411,
Silver Spring, MD 20993–0002, 301–
796–2090.
SUPPLEMENTARY INFORMATION:
Time and Date: 1 p.m.–3 p.m., April 20,
2010 (Closed).
Place: Teleconference.
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 Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Healthy Passages Longitudinal
Study of Youth, FOA DP 10–007.’’
Contact Person for More Information:
Michael Dalmat, DRPH., Scientific Review
Officer, National Center for Chronic Disease
and Health Promotion, Office of the Director,
Extramural Research Program Office, 4770
Buford Highway, NE., Mailstop K–92,
Atlanta, GA 30341, Telephone: (770) 488–
6423, E-mail: MED1@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.
Dated: February 10, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
BILLING CODE 4163–18–P
15:26 Feb 19, 2010
Food and Drug Administration
BILLING CODE 4163–18–P
[FR Doc. 2010–3146 Filed 2–19–10; 8:45 am]
VerDate Nov<24>2008
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Special Emphasis Panel (SEP):
Healthy Passages Longitudinal Study of
Youth, Funding Opportunity
Announcement (FOA) DP 10–007,
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:
Dated: February 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
Dated: February 11, 2010.
Andre Tyler,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
I. Ingredients Affected by This Notice
We are currently evaluating the safety
and effectiveness of 13 active
ingredients found eligible for possible
addition to an OTC drug monograph via
the TEA process described in 21 CFR
330.14. The ingredients under review
are shown in table 1 of this document:
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 75, Number 34 (Monday, February 22, 2010)]
[Notices]
[Pages 7604-7606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3320]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0079]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Graphic Cigarette Warning Labels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on the Experimental Study of Graphic Cigarette
Warning Labels that is being conducted in support of the graphic label
statement provision of the Family Smoking Prevention and Tobacco
Control Act (the Tobacco Control Act).
DATES: Submit written or electronic comments on the collection of
information by April 23, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://
[[Page 7605]]
www.regulations.gov. Submit written comments on the collection of
information to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
All comments should be identified with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3794,
JonnaLynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Experimental Study of Graphic Cigarette Warning Labels
Tobacco products are responsible for more than 440,000 deaths each
year. The Centers for Disease Control and Prevention report that
approximately 46 million U.S. adults smoke cigarettes in the United
States, even though this behavior will result in death or disability
for half of all regular users. Paralleling this enormous health burden
is the economic burden of tobacco use, which is estimated to total $193
billion annually in medical expenditures and lost productivity. Curbing
the significant adverse consequences of tobacco use is one of the most
important public health goals of our time. One way to do this is
through health warnings that describe and graphically depict the harm
caused by cigarette use.
On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Tobacco Control Act granted FDA
important new authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors. Section 201 of the Tobacco Control
Act, which amends section 4 of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333), requires FDA to issue ``regulations
that require color graphics depicting the negative health consequences
of smoking to accompany the label statements specified in subsection
(a)(1).'' FDA conducts research relating to tobacco products under its
statutory authority in section 1103(d)(2)(C) of the Federal Food, Drug,
and Cosmetic Act, as amended by the Tobacco Control Act, to conduct
research ``relating to foods, drugs, cosmetics, devices, and tobacco
products in carrying out the act.'' The study proposed here is an
effort by FDA to collect data concerning graphic warnings on cigarette
packages and their impact on consumer perceptions, attitudes, and
behavior with respect to smoking.
The study, the Experimental Study of Graphic Cigarette Warning
Labels, is a voluntary experimental survey of consumers. The purpose of
the study is to assess the effectiveness of various graphic warnings on
cigarette packs for achieving three communication goals: (1) Conveying
information about various health risks of smoking, (2) encouraging
cessation of smoking among current smokers, and (3) discouraging
initiation of smoking among youth and former smokers. The study will
collect data from various groups of consumers, including current
smokers aged 13 years and older, former smokers aged 13 years and
older, and non-smokers aged between 13 and 25 years who may be
susceptible to initiation of smoking. The study goals are to: (1)
Measure consumer attitudes, beliefs, and intended behaviors related to
cigarette smoking in response to graphic warning labels; (2) determine
whether consumer responses to graphic warning labels differ across
various groups based on smoking status, age, or other demographic
variables; and (3) evaluate the relative effectiveness of various
graphic images associated with each of the nine warning statements
specified in the Tobacco Control Act for achieving each of the
communication goals. The information collected from the study is
necessary to inform the agency's efforts to implement the mandatory
graphic warnings required by the Tobacco Control Act.
The experimental study data will be collected from participants of
an Internet panel of approximately 43,000 people. Participation in the
experimental study is voluntary.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Portion of Study Respondents per Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-test 60 1 60 0.5 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener 15,000 1 15,000 0.016 240
--------------------------------------------------------------------------------------------------------------------------------------------------------
Experimental Survey 5,400 1 5,400 0.5 2,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ................. 1 15,460 ..................... 2,970
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 7606]]
FDA's burden estimate is based on prior experience with Internet
panel experiments similar to the study proposed here. Sixty panel
members will take part in a pre-test of the study, estimated to last 30
minutes (0.5 hours), for a total of 30 hours. Approximately 15,000
respondents will complete a screener to determine eligibility for
participation in the study, estimated to take 1 minute (0.016 hours),
for a total of 125 hours. Fifty-four hundred (5,400) respondents will
complete the full study, estimated to last 30 minutes (0.5 hours), for
a total of 2,700 hours. The total estimated burden is 2,970 hours.
Dated: February 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3320 Filed 2-19-10; 8:45 am]
BILLING CODE 4160-01-S
