[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39449-39450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17044]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0180]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Generic Clearance for 
the Collection of Quantitative Data on Tobacco Products and 
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 10, 2018.

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 emailed to <a href="/cdn-cgi/l/email-protection#335c5a41526c4046515e5a40405a5c5d735c5e511d565c431d545c45"><span class="__cf_email__" data-cfemail="93fcfae1f2cce0e6f1fefae0e0fafcfdd3fcfef1bdf6fce3bdf4fce5">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0810. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
<a href="/cdn-cgi/l/email-protection#2e7e7c6f7d5a4f48486e484a4f0046465d00494158"><span class="__cf_email__" data-cfemail="8ddddfccdef9ecebebcdebe9eca3e5e5fea3eae2fb">[email protected]</span></a>.

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.

[[Page 39450]]

Generic Clearance for the Collection of Quantitative Data on Tobacco 
Products and Communications; OMB Control Number 0910-0810--Extension

    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.
    To ensure that these health communication messages have the highest 
potential to be received, understood, and accepted by those for whom 
they are intended, the 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 voluntary 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 voluntary 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 the materials are 
still in the developmental stage.
    In the Federal Register of February 13, 2018 (83 FR 6190), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One PRA-related comment was received.
    Comment: The comment recommends that FDA should research and 
develop communications about educating adults about the continuum of 
risk, and educating adults to not provide tobacco products to youth.
    Response: FDA appreciates the comment. The content and focus on 
studies submitted through this generic clearance will depend on Agency 
priorities and needs, and is not yet determined at this time.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Screener........................         130,500               1         130,500        0.083 (5          10,831
                                                                                        minutes)
Self-Administered Surveys.......          27,000               1          27,000        0.33 (20           8,910
                                                                                        minutes)
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          19,741
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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. The burden for this information collection 
extension is proposed to increase by 12,613 hours since the last OMB 
approval. The burden increase is due to an increase in the number of 
respondents and the categories of respondents.

    Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17044 Filed 8-8-18; 8:45 am]
BILLING CODE 4164-01-P


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