Notice2021-12256
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 11, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 111 (Friday, June 11, 2021)</title>
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[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31328-31330]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under
[[Page 31329]]
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,
<a href="/cdn-cgi/l/email-protection#0b5b594a587f6a6d6d4b6d6f6a25636378256c647d"><span class="__cf_email__" data-cfemail="29797b687a5d484f4f694f4d480741415a074e465f">[email protected]</span></a>.
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.
[[Page 31330]]
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
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