
[Federal Register Volume 79, Number 235 (Monday, December 8, 2014)]
[Proposed Rules]
[Pages 72685-72686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28635]


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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 Qualitative 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

[[Page 72686]]

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 January 
7, 2015.

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 Qualitative Data on 
Tobacco Products and Communications.'' Also include the FDA 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, 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 Qualitative Data on Tobacco 
Products and Communications--(OMB Control Number 0910--New)

    Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
393(d)(2)(D)), FDA is authorized to conduct educational and public 
information programs.
    In conducting studies relating to the regulation and communications 
related to tobacco products, FDA will need to employ formative 
qualitative research including focus groups and/or in-depth interviews 
(IDIs) to assess knowledge and perceptions about tobacco-related topics 
with specific target audiences. The information collected will serve 
two major purposes. First, formative research will provide critical 
knowledge about target audiences. FDA must first understand people's 
knowledge and perceptions about tobacco related topics prior to 
developing survey/research questions as well as stimuli for 
experimental studies. Second, initial testing will allow FDA to assess 
consumer understanding of survey/research questions and study stimuli. 
Focus groups and/or IDIs with a sample of the target audience will 
allow FDA to refine the survey/research questions and study stimuli 
while they are still in the developmental stage. FDA will collect, 
analyze, and interpret information gathered through this generic 
clearance in order to: (1) Better understand characteristics of the 
target audience--its perceptions, knowledge, attitudes, beliefs, and 
behaviors--and use these in the development of appropriate survey/
research questions, study stimuli, or communications; (2) more 
efficiently and effectively design survey/research questions and study 
stimuli; and (3) more efficiently and effectively design experimental 
studies.
    FDA is requesting approval of this new generic clearance for 
collecting information through the use of qualitative methods (i.e., 
individual interviews, small group discussions, and focus groups) for 
studies involving all tobacco products regulated by FDA. This 
information will be used as a first step to explore concepts of 
interest and assist in the development of quantitative study proposals, 
complementing other important research efforts in the Agency. This 
information may also be used to help identify and develop communication 
messages, which may be used in education campaigns. Focus groups play 
an important role in gathering information because they allow for an 
in-depth understanding of individuals' attitudes, beliefs, motivations, 
and feelings. Focus group research serves the narrowly defined need for 
direct and informal public opinion on a specific topic.
    In the Federal Register of August 1, 2014 (79 FR 44779), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received. However, only 
one comment was PRA-related.
    (Comment) One comment was supportive of the information collection, 
stating that such ``collections are, in fact, essential.'' The 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 the 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, FDA advisory committees, and/or 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       Hours per        Total hours
                                 respondents     respondent       responses         response
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In Person Individual In-Depth             350               1             350  1................             350
 Interviews.
General Public Focus Group             18,850               1          18,850  1.5..............          28,275
 Interviews.
Telephone Screening                     4,800               1           4,800  .08..............             384
 Interviews.                                                                   (5 minutes)......
Telephone Individual In-Depth              50               1              50  1................              50
 Interviews.
                              ----------------------------------------------------------------------------------
    Total....................          24,050  ..............  ..............  .................          29,059
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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 pretest may 
vary depending on the nature of the material or message being tested 
and the target audience. Table 1 provides examples of the types of 
studies that may be administered and estimated burden levels during the 
3-year period. Time to read, view, or listen to the message being 
tested is built into the ``Hours per Response'' figures.

    Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28635 Filed 12-5-14; 8:45 am]
BILLING CODE 4164-01-P


