[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Notices]
[Pages 41696-41697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Quantitative Testing as Used by the Food and Drug 
Administration Center for Tobacco Products

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 quantitative testing as used by the Food 
and Drug Administration Center for Tobacco Products.

DATES: Submit either electronic or written comments on the collection 
of information by September 15, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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.

Quantitative Testing as Used by the Food and Drug Administration Center 
for Tobacco Products (OMB Control Number 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. 393(d)(2)(D)), FDA's 
Center for Tobacco Products will create and use a variety of media to 
inform and educate the public, tobacco retailers, and health 
professionals about the risks of tobacco use, how to quit using tobacco 
products, and FDA's role in regulating tobacco.

[[Page 41697]]

    To ensure that such health communication messages have the highest 
potential to be received, understood, and are accepted by those for 
whom they are intended, FDA's Center for Tobacco Products will conduct 
research and studies relating to the control and prevention of disease. 
In conducting such research, FDA will employ formative pretests. 
Formative pretests are conducted on a small scale, and their focus is 
on developing and assessing the likely effectiveness of communications 
with specific target audiences. This type of research involves (1) 
assessing audience knowledge, attitudes, behaviors, and other 
characteristics for the purpose of determining the need for and 
developing health messages, communication strategies, and public 
information programs; and (2) pretesting these health messages, 
strategies, and program components while they are in developmental form 
to assess audience comprehension, reactions, and perceptions.
    Formative pretesting is a staple of best practices in 
communications research. Obtaining feedback from intended audiences 
during the development of messages and materials is crucial for the 
success of every communication program. The purpose of obtaining 
information from formative pretesting is that it allows FDA to improve 
materials and strategies while revisions are still affordable and 
possible. Formative pretesting can also avoid potentially expensive and 
dangerous unintended outcomes caused by audiences' interpreting 
messages in a way that was not intended by the drafters. By maximizing 
the effectiveness of messages and strategies for reaching targeted 
audiences, the frequency with which tobacco communication messages need 
to be modified should be greatly reduced.
    The information collected will serve the primary purpose of 
providing FDA information about the perceived effectiveness of 
messages, advertisements, and materials in reaching and successfully 
communicating with their intended audiences. Quantitative testing 
messages and other materials with a sample of the target audience will 
allow FDA to refine messages, advertisements, and materials, including 
questionnaires or images, directed at consumers while they are still in 
the developmental stage.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                      Number of
                    Activity                         Number of      responses per     Total annual      Average burden per  response       Total hours
                                                    respondents       respondent       responses
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Self-Administered Surveys.......................          30,300                1           30,300   0.33 (20 minutes).................           9,999
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents to be included in each new survey will 
vary, depending on the nature of the material or message being tested 
and the target audience.

    Dated: July 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16795 Filed 7-16-14; 8:45 am]
BILLING CODE 4164-01-P