[Federal Register Volume 75, Number 39 (Monday, March 1, 2010)]
[Notices]
[Pages 9225-9226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4098]
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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:
[email protected].
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