Document ID: FDA-2014-N-0987-0012
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 Qualitative Data on Tobacco Products and Communications
Posted Date: 2018-05-16T04:00Z

[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Notices]
[Pages 22690-22691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10457]

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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 Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by June 
15, 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 [email protected]. All 
comments should be identified with the OMB control number 0910-0796. 
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, 
[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 
in-depth 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 
understand people's knowledge and perceptions about tobacco-related 
topics before 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, 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 at FDA. 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 individual 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 November 17, 2017 (82 FR 54351), FDA published a 60-day 
notice requesting public comment on the proposed collection of 
information. FDA received one comment by a private citizen that was 
PRA-related.
    (Comment) The commenter stated that FDA should use the data we have 
collected in the past instead of collecting new information. The 
comment does not go in detail or provide any alternatives.
    (Response) This collection is a valuable tool for conducting 
research. The studies FDA has conducted through this collection of 
information have been essential in helping FDA meet its mission as a 
science-based regulatory agency and implementing the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31). Future submissions 
submitted under this generic clearance will continue to assist FDA in 
its mission to protect and promote public health.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 22691]]

                                                     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  .083 (5 minutes).........................             149
Focus Group Interviews.......................           4,701               1           4,701  1.5......................................           7,052
Focus Group Screener.........................           3,996               1           3,996  .25 (15 minutes).........................             999
Usability Testing............................           2,322               1           2,322  .5 (30 minutes)..........................           1,161
Usability Testing Screener...................           2,028               1           2,028  .083 (5 minutes).........................             168
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    Total....................................  ..............  ..............  ..............  .........................................          10,621
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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 a 
3-year period. Time to read, view, or listen to the message being 
tested is built into the ``Hours per Response'' figures.
    FDA has updated the estimated burden that was published in the 60-
day notice. The estimated burden for this collection has increased by 
4,437 hours from 6,184 to 10,621. FDA attributes this increase to 
adding usability testing, and increasing the overall number of studies 
planned the next 3 years.

    Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10457 Filed 5-15-18; 8:45 am]
 BILLING CODE 4164-01-P