Document ID: FDA-2014-N-0987-0003
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2014-11-28T05:00Z

[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70873-70875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 
December 29, 2014.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Generic Clearance for the Collection of Quantitative Data on 
Tobacco Products and Communications.'' Also include the FDA docket 
number found in brackets in the heading of this document.

[[Page 70874]]

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

Generic Clearance for the Collection of Quantitative Data on Tobacco 
Products and Communications--(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 (CTP) 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 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 the materials are 
still in the developmental stage.
    In the Federal Register of July 17, 2014 (79 FR 41696), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Four comments were received, but only two 
comments were PRA-related.
    (Comment 1) One comment was supportive of the information 
collection, stating they ``support CTP's proposal to conduct formative 
pretests to ensure that health communication messages are received, 
understood and accepted by the intended audiences'' and that they 
believe the proposed information collection is necessary and will have 
practical utility. The comment also stated that CTP's projection of the 
burden of the proposed collection effort seems reasonable. In addition, 
the comment suggested that FDA consult with FDA's Risk Communication 
Advisory Committee on proposed information collections.
    (Response) FDA agrees that the request in this collection of 
information is necessary and that the proposed burden is reasonable. 
Consultation with other U.S. Department of Health and Human Services 
(HHS) Agencies, FDA advisory committees, and/or the public will occur 
when appropriate.
    (Comment 2) One comment was supportive of the data collection 
stating that the ``collections are, in fact, essential.'' That comment 
also made suggestions about what the specific goals of messages tested 
in information collections included under this generic collection 
should focus on, and suggested that those collections be made available 
for further public comments.
    (Response) FDA agrees that the request in this collection of 
information is essential to the mission of FDA as a science-based 
Agency in its implementation of the Tobacco Control Act. Although we 
appreciate suggestions for the content of future submissions submitted 
under this generic clearance, ultimately such decisions will be driven 
by needs determined by the Agency in consultation with other HHS 
Agencies and the public when appropriate.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting 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: November 20, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28106 Filed 11-26-14; 8:45 am]
BILLING CODE 4164-01-P