Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Review; Experimental Study of Graphic Cigarette Warning Labels, 72355-72356 [2012-29321]
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Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices
72355
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Number of
respondents
21 CFR Section
Total ..............................................................................
1There
[FR Doc. 2012–29327 Filed 12–4–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No FDA–2012–N–0273]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Review; Experimental Study
of Graphic Cigarette Warning Labels
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a reinstatement 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 January 4,
2013.
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 emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0668. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK4VPTVN1PROD with
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
240
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
ACTION:
Number of
responses per
respondent
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
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
VerDate Mar<15>2010
17:19 Dec 04, 2012
Jkt 229001
The Tobacco Control Act (Pub. L.
111–31) amends the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) to
grant FDA authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health and to reduce
tobacco use by minors.
The purpose of this submission is to
request OMB approval to conduct Webbased surveys to evaluate the relative
effectiveness of various graphic health
warnings on cigarette packs, which will
inform the Agency’s efforts to
implement the mandatory graphic
warnings required by the Tobacco
Control Act.
Experimental Study of Graphic
Cigarette Warning Labels (OMB Control
Number 0910–0668—Reinstatement)
The current approval for this
information collection expired October
31, 2012. FDA seeks to reinstate the
collection and to reflect that there is no
change in the reporting burden. At this
time, the Agency is not collecting the
information, but awaits OMB review
and approval, and therefore believes
that we are not in violation of the PRA.
Tobacco products are responsible for
more than 400,000 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.
On June 22, 2009, the President
signed the Tobacco Control Act (Pub. L.
111–31) into law. The Tobacco Control
Act granted FDA 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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
depicting the negative health
consequences of smoking to accompany
the label statements specified in
subsection (a)(1).’’ 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.
On June 22, 2011, FDA issued a final
rule in the Federal Register of June 22,
2011 (76 FR 36628), entitled ‘‘Required
Warnings for Cigarette Packages and
Advertisements,’’ which specified nine
graphic images to accompany the new
textual warnings for cigarettes.
Although the rule was scheduled to
become effective 15 months after it
issued, a panel of the U.S. Court of
Appeals of the District of Columbia
held, on August 24, 2012, that the rule
in its current form violates the First
Amendment. FDA expects that the
information that FDA proposes to
collect will be relevant to FDA’s
regulation of cigarette warnings no
matter the final outcome of the current
litigation.
This study, the Experimental Study of
Graphic Cigarette Warning Labels, is a
voluntary annual 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
E:\FR\FM\05DEN1.SGM
05DEN1
72356
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices
the Tobacco Control Act for achieving
each of the communication goals. The
information collected from the study
will help inform the Agency’s efforts to
implement the mandatory graphic
health 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.
In the Federal Register of March 27,
2012 (77 FR 18250), FDA published a
60-day notice requesting public
comment on its proposed collection of
information. FDA received eight
comments that were not PRA-related
and that were outside the scope of this
collection of information. FDA also
received a comment that asked FDA to
provide more detail about the design of
the proposed consumer research study
to allow for meaningful public
comments. The commenter also
encouraged FDA to provide additional
information for public comment,
including details of the protocol, screen,
questionnaire, and actual graphic
warnings images to be used with study
participants to enhance the quality,
utility, and clarity of the information to
be collected and further the goals of the
PRA to ensure the greatest possible
public benefit from and maximize the
utility of the information. FDA notes in
response to this comment that the study
and copies of the instruments used to
collect this information are described in
detail as part of the overall package
submitted to OMB for review. The study
and copies of the instrument were made
available to the public during the
original information collection period.
They will also be available to the public
at www.reginfo.gov once OMB receives
the package for review.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
Portion of study
No. of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Pretest ............................................................................
Screener .........................................................................
Experimental Survey ......................................................
60
15,000
5,400
1
1
1
60
15,000
5,400
0.5 (30 minutes) ..
0.016 (1 minute) ..
0.5 (30 minutes) ..
30
240
2,700
Total ........................................................................
........................
........................
........................
.............................
2,970
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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 pretest 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 240 hours. Fifty-four hundred
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
(30 hours plus 240 hours plus 2,700
hours).
Dated: November 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–29321 Filed 12–4–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with
[Docket No. FDA–2011–N–0656]
Animal Drug User Fee Act; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
17:19 Dec 04, 2012
Jkt 229001
Notice of meeting; request for
comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing the following
meeting: Animal Drug User Fee Act. The
topic to be discussed is proposed
recommendations for the
reauthorization of the Animal Drug User
Fee Act (ADUFA III).
Date and Time: The meeting will be
held on December 18, 2012, from 9 a.m.
to 12 p.m.
Location: The meeting will be held at
FDA’s Metro Park North Campus, 7519
Standish Pl., third floor, Meeting Room
A, Rockville, MD 20855. There is
parking near the building.
Contact: Jacqueline Farmer, Center for
Veterinary Medicine (HFV–10), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
8695, FAX: 240–276–9744, email:
ADUFAReauthorization@fda.hhs.gov.
Registration and Requests for Oral
Presentations: Send registration
information (including name, title, firm
name, address, telephone, and fax
number), and written material and
requests to make oral presentations, to
the contact person by December 11,
2012.
If you need special accommodations
due to a disability, please contact
Jacqueline Farmer at least 7 days in
advance.
Transcripts: Please be advised that as
soon as a transcript is available, it will
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Comments: Interested persons may
submit either written comments
regarding this meeting to the Division of
Dockets Management (see Transcripts)
or electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of 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, and
will be posted to the docket at https://
www.regulations.gov. So that FDA can
consider comments and revise the
recommendations as necessary, we
request that comments be submitted to
the docket by January 4, 2013.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\05DEN1.SGM
05DEN1
]]>Agencies
[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72355-72356]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29321]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No FDA-2012-N-0273]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Review; Experimental Study of
Graphic Cigarette Warning Labels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
reinstatement 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 January
4, 2013.
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 emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0668.
Also include the FDA docket number found in brackets in the heading of
this document.
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 compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
The Tobacco Control Act (Pub. L. 111-31) amends the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health and to reduce tobacco use by
minors.
The purpose of this submission is to request OMB approval to
conduct Web-based surveys to evaluate the relative effectiveness of
various graphic health warnings on cigarette packs, which will inform
the Agency's efforts to implement the mandatory graphic warnings
required by the Tobacco Control Act.
Experimental Study of Graphic Cigarette Warning Labels (OMB Control
Number 0910-0668--Reinstatement)
The current approval for this information collection expired
October 31, 2012. FDA seeks to reinstate the collection and to reflect
that there is no change in the reporting burden. At this time, the
Agency is not collecting the information, but awaits OMB review and
approval, and therefore believes that we are not in violation of the
PRA.
Tobacco products are responsible for more than 400,000 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.
On June 22, 2009, the President signed the Tobacco Control Act
(Pub. L. 111-31) into law. The Tobacco Control Act granted FDA
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).'' 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.
On June 22, 2011, FDA issued a final rule in the Federal Register
of June 22, 2011 (76 FR 36628), entitled ``Required Warnings for
Cigarette Packages and Advertisements,'' which specified nine graphic
images to accompany the new textual warnings for cigarettes. Although
the rule was scheduled to become effective 15 months after it issued, a
panel of the U.S. Court of Appeals of the District of Columbia held, on
August 24, 2012, that the rule in its current form violates the First
Amendment. FDA expects that the information that FDA proposes to
collect will be relevant to FDA's regulation of cigarette warnings no
matter the final outcome of the current litigation.
This study, the Experimental Study of Graphic Cigarette Warning
Labels, is a voluntary annual 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
[[Page 72356]]
the Tobacco Control Act for achieving each of the communication goals.
The information collected from the study will help inform the Agency's
efforts to implement the mandatory graphic health 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.
In the Federal Register of March 27, 2012 (77 FR 18250), FDA
published a 60-day notice requesting public comment on its proposed
collection of information. FDA received eight comments that were not
PRA-related and that were outside the scope of this collection of
information. FDA also received a comment that asked FDA to provide more
detail about the design of the proposed consumer research study to
allow for meaningful public comments. The commenter also encouraged FDA
to provide additional information for public comment, including details
of the protocol, screen, questionnaire, and actual graphic warnings
images to be used with study participants to enhance the quality,
utility, and clarity of the information to be collected and further the
goals of the PRA to ensure the greatest possible public benefit from
and maximize the utility of the information. FDA notes in response to
this comment that the study and copies of the instruments used to
collect this information are described in detail as part of the overall
package submitted to OMB for review. The study and copies of the
instrument were made available to the public during the original
information collection period. They will also be available to the
public at www.reginfo.gov once OMB receives the package for review.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of
Portion of study No. of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest....................................... 60 1 60 0.5 (30 minutes)........................ 30
Screener...................................... 15,000 1 15,000 0.016 (1 minute)........................ 240
Experimental Survey........................... 5,400 1 5,400 0.5 (30 minutes)........................ 2,700
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 2,970
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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 pretest 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 240 hours. Fifty-four hundred 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 (30 hours
plus 240 hours plus 2,700 hours).
Dated: November 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29321 Filed 12-4-12; 8:45 am]
BILLING CODE 4160-01-P
