Document ID: FDA-2014-N-0987-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Posted Date: 2014-12-12T05:00Z

[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44779-44780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18195]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0005]

Agency Information Collection Activities; Proposed Collection; 
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 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 Generic Clearance for the Collection of 
Qualitative Data on Tobacco Products and Communications.

DATES: Submit either electronic or written comments on the collection 
of information by September 30, 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, PRAStaff@fda.hhs.gov.

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.

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

[[Page 44780]]

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 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.
    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  response              Total hours
                                                   respondents      respondent      responses
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In Person Individual In-Depth Interviews.......             350               1             350  1......................................             350
General Public Focus Group Interviews..........          18,850               1          18,850  1.5....................................          28,275
Telephone Screening Interviews.................           4,800               1           4,800  .08 (5 minutes)........................             384
Telephone Individual In-Depth Interviews.......              50               1              50  1......................................              50
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    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: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18195 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P