[Federal Register Volume 77, Number 160 (Friday, August 17, 2012)]
[Notices]
[Pages 49819-49820]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0876]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Pretesting of Tobacco Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on pretesting of tobacco 
communications.

DATES: Submit either electronic or written comments on the collection 
of information by October 16, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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: 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: 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, including 
each proposed extension of an existing 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.

Pretesting of Tobacco Communications--(OMB Control Number 0910-0674)--
Extension

    In order to conduct educational and public information programs 
relating to tobacco use, as authorized by section 903(d)(2)(D) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) and to 
develop stronger health warnings on tobacco packaging as authorized by 
the Family Smoking Prevention and Tobacco Control Act (Tobacco Control 
Act), it is beneficial for FDA to conduct research and studies relating 
to the control and prevention of disease as authorized by section 301 
of the Public Health Service Act (42 U.S.C 241(a)). In conducting such 
research, FDA will employ formative pretests to assess the likely 
effectiveness of tobacco communications with specific target audiences. 
The information collected will serve two major purposes. First, as 
formative research it will provide the critical knowledge needed about 
target audiences. FDA must first understand critical influences on 
people's decisionmaking process when choosing to use, not use, or quit 
using tobacco products. In addition to understanding the decisionmaking 
processes of adults, it is also critical to understand the 
decisionmaking processes among adolescents (ages 13 to 17), where 
communications will aim to discourage tobacco use before it starts. 
Knowledge of these decisionmaking processes will be applied by FDA to 
help design effective communication strategies, messages, and warning 
labels. Second, as initial testing, it will allow FDA to assess the 
potential effectiveness of messages and materials in reaching and 
successfully communicating with their intended audiences. Pretesting 
messages with a sample of the target audience will allow FDA to refine 
messages while they are still in the developmental stage. By utilizing 
appropriate qualitative and quantitative methodologies, FDA will be 
able to: (1) Better understand characteristics of the target audience--
its attitudes, beliefs, and behaviors--and use risk communications; (2) 
more efficiently and effectively design messages and select formats 
that have the greatest potential to influence the target audience's 
attitudes and behavior in a favorable way; (3) determine the best 
promotion and distribution channels to reach the target audience with 
appropriate messages; and (4) expend limited program resource dollars 
wisely and effectively.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 49820]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Individual In-Depth Interviews             360               1             360  0.75 (45                     270
                                                                                 minutes).
General Public Focus Group                 144               1             144  1.5 hours.......             216
 Interviews.
Intercept Interviews: Central              600               1             600  0.25 (15                     150
 Location.                                                                       minutes).
Intercept Interviews:               \2\ 10,000               1          10,000  0.08 (5 minutes)             800
 Telephone.
Self-Administered Surveys.....           2,400               1           2,400  0.25 (15                     600
                                                                                 minutes).
Gatekeeper Reviews............             400               1             400  0.50 (30                     200
                                                                                 minutes).
Omnibus Surveys...............           2,400               1           2,400  0.17 (10                     408
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total (General Public)....          16,304  ..............  ..............  ................           2,644
Physician Focus Group                      144               1             144  1.5 hours.......             216
 Interviews.
    Total (Physician).........             144  ..............  ..............  ................             216
                               ---------------------------------------------------------------------------------
    Total (Overall)...........          16,448  ..............  ..............  ................           2,860
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Brief interviews with callers to test message concepts and strategies following their call-in request to the
  FDA Center for Tobacco Products 1-800 number.

    The number of respondents to be included in each new pretest will 
vary, depending on the nature of the material or message being tested 
and the target audience. However, for illustrative purposes, table 1 
provides examples of the types of studies that may be administered and 
estimated burden levels that may be incurred during each year of the 3-
year period. Time to read, view, or listen to the message being tested 
is built into the ``Hours per Response'' figures.

    Dated: August 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20206 Filed 8-16-12; 8:45 am]
BILLING CODE 4160-01-P