[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Notices]
[Pages 47600-47601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0084]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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.

DATES:  Fax written comments on the collection of information by 
September 7, 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 [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
the title ``Pretesting of Tobacco Communications.'' 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, [email protected].

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.

Pretesting of Tobacco Communications--0910-NEW

    In order to conduct educational and public information programs 
relating to tobacco use, as authorized by section 1003(d)(2)(D) of the 
Federal Food Drug and Cosmetic Act (21 U.S.C. section 393) and to 
develop effective tobacco-related communications as authorized by the 
Family Smoking Prevention and Tobacco Control Act (Tobacco Control 
Act), FDA must conduct research and studies relating to the control and 
prevention of disease (also 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, formative research will 
provide critical knowledge about target audiences such as adolescents, 
adults, health care professionals, and tobacco retailers. 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. FDA must also understand the 
general beliefs of retailers in the tobacco product supply chain. 
Retailers play a key role in the success of tobacco control as they are 
directly impacted by many of the regulations FDA will issue under the 
Tobacco Control Act. FDA must determine retailers' informational needs 
and the most effective communication channels and formats for reaching 
and educating them about new regulations. This knowledge will allow FDA 
to engage retailers as partners in tobacco control by better equipping 
them with the tools needed to comply with these regulations. FDA will 
apply knowledge of these decisionmaking processes to design effective 
communication strategies and messages. Second, initial testing 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 these in the development of effective 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.
    In the Federal Register of March 1, 2010 (75 FR 9225), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received comments from four public 
entities, including two corporations, one nonprofit organization, and 
one city health department. Comments supported FDA taking a science-
based approach to its communication activities. None of the comments 
objected to the estimated annual reporting burden or questioned

[[Page 47601]]

the practical utility of the information to be collected.
    FDA acknowledges one request for additional details on the 
information to be collected and the planned research methodology, but 
notes that its notice asked for comment on FDA's request for a generic 
clearance to collect information related to the formative pretesting of 
tobacco communication messages. Under this generic clearance, details 
of individual studies will be tailored to specific communications-
related questions. For each study FDA would request under this 
clearance, FDA will provide OMB with details on the information 
collection (e.g., research question(s), methodology). The communication 
development process will inform the purpose of the data collection and 
hence its methodology. For very early message development, qualitative 
research such as focus groups or in-depth interviews will be 
appropriate. At later communications development stages, qualitative as 
well as more quantitative data collection may be needed.
    One comment noted that FDA separately requested comment on a 
specific study of the efficacy of graphic cigarette warning labels 
(Docket No. FDA-2010-N-0079). In response to this comment, and to avoid 
apparent duplication of effort, FDA agrees that it will not conduct any 
pretesting of tobacco warning labels under this proposed generic 
clearance. Further, FDA will not use studies conducted under this 
generic clearance to make regulatory policy or enforcement decisions. 
However, FDA may conduct research under this generic clearance 
concerning the development of informational campaigns that FDA may 
undertake to explain changes to, and the implications of, tobacco 
product warning label regulations.
    After careful consideration, FDA determined that a comment 
suggesting limiting pretesting to adults to minimize the burden of 
information collections on the public would reduce the utility of study 
results. This suggestion goes against commonly accepted communication 
practice, and the advice of FDA's Risk Communication Advisory 
Committee, to target intended audiences with messages tailored to their 
specific needs. Segmenting pretesting by audience will produce results 
that will better inform FDA's development of messages relevant to 
intended audiences' specific needs, beliefs, and attitudes. A major 
objective of FDA tobacco communications will be to discourage tobacco 
use by adolescents before they start. Therefore, it is critical that 
FDA understand the decisionmaking processes among 13 to 17 year olds. 
Also, the suggestion to eliminate the pretesting of messages delivered 
across multiple platforms (e.g., television, print, radio) ignores a 
fundamental research goal of matching appropriate messages with 
effective distribution channels. Limiting pretesting in this way would 
leave FDA basing its communication activities on assumptions rather 
than science-based research.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                          No. of          Annual Frequency       Total Annual          Hours per
               Type of  Respondents                     Respondents         per Response           Responses           Response           Total Hours
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Adolescents 13 to 17, adults 18+, health care                   16,448                     1              16,448              0.1739               2,860
 professionals, tobacco retailers
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Total                                                           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.


    Dated: August 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19356 Filed 8-5-10; 8:45 am]
BILLING CODE 4160-01-S