Document ID: FDA-2010-N-0084-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pretesting of Tobacco Communications
Posted Date: 2010-03-01T05:00Z

[Federal Register: March 1, 2010 (Volume 75, Number 39)]
[Notices]               
[Page 9225-9226]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01mr10-89]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on pretesting of tobacco communications.

DATES:  Submit written or electronic comments on the collection of 
information by April 30, 2010.

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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, e-mail: 
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.

Pretesting of Tobacco Communications

    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

[[Page 9226]]

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. Frequency of Response: On occasion. Affected 
Public: Individuals or households; Type of Respondents: Members of the 
public, healthcare professionals; organizational representatives.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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    Type of           No. of         Annual Frequency       Total Annual        Hours per
  Respondents      Respondents         per Response          Responses           Response         Total Hours
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Adolescents 13-            16,448                     1             16,448             0.1739              2,860
 17, and
 Adults 18+
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Total                                                                                                      2,860
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: February 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4098 Filed 2-26-10; 8:45 am]
BILLING CODE 4160-01-S