[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31328-31330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12256]


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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 or Agency) 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: Submit written comments (including recommendations) on the 
collection of information by July 12, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under

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Review--Open for Public Comments'' or by using the search function. The 
OMB control number for this information collection is 0910-0796. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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 0910-0796--Extension

    Under section 1003(d)(2)(D) of 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, usability testing, and/or 
indepth interviews (IDIs) to assess knowledge and perceptions about 
tobacco-related topics with specific target audiences. The information 
collected will serve three 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, by collecting communications 
usability information, FDA will be able to serve and respond to the 
ever-changing demands of consumers of tobacco products. Additionally, 
we will be able to determine the best way to present messages. Third, 
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, 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 an extension of this generic 
clearance for collecting information using 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 
indepth 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.
    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. Our estimated 
burden for the information collection reflects an overall increase of 
5,641 hours and a corresponding increase of 16,585 responses. We 
attribute this adjustment to the number of study responses used during 
the current approval and now estimated for the next 3 years.
    In the Federal Register of September 29, 2020 (85 FR 60999), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments; however, only one 
was PRA-related.
    (Comment) The comment expressed support for FDA's collection of 
qualitative research on tobacco products. The comment stated further 
that while FDA indicates that this research will meet the ``narrowly 
defined need for direct and informal public opinion on a specific 
topic,'' the Agency has recently used this work for broader purposes, 
including informing the Proposed Rule for graphic health warnings.''
    (Response) FDA appreciates the support for conducting qualitative 
research on tobacco products. FDA disagrees with the comment suggesting 
that the Agency has used its qualitative generic collection for 
``broader purposes'' than contemplated by the generic collection. 
Review of a generic collection occurs in two stages: (1) A full PRA 
review of the generic clearance ICR, which includes the general 
approach and methodology, at least once every 3 years and (2) an 
expedited review of the individual collections that fall within the 
scope of the generic clearance. OMB reviewed the individual 
collection[s] that this comment cites and approved the collection, 
having determined that it was appropriately within the scope of the 
generic clearance.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
              Type of interview                  Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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In-Person Individual IDIs...................           1,092               1           1,092  1.........................................           1,092
IDI Screener................................           1,800               1           1,800  0.083 (5 minutes).........................             150
Focus Group Screener........................          19,385               1          19,385  0.25 (15 minutes).........................           4,846
Focus Group Interviews......................           5,897               1           5,897  1.5.......................................           8,846
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    Total...................................  ..............  ..............  ..............  ..........................................          14,934
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



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    Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12256 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P