[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 60999-61001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21452]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]


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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing 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 November 30, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 30, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

[[Page 61000]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-0987 for ``Generic Clearance for the Collection of 
Qualitative Data on Tobacco Products and Communications.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, including 
each proposed extension of an existing 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 0910-0796--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 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 
in-depth understanding of individuals' attitudes, beliefs, motivations, 
and feelings. Focus group

[[Page 61001]]

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
       Type of interview           Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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In-Person Individual In-depth            1,092               1           1,092  1...............           1,092
 Interviews.
In-depth Interview (IDI)                 1,800               1           1,800  0.083 (5                     150
 Screener.                                                                       minutes).
Focus Group Screener..........          19,385               1          19,385  0.25 (15                   4,846
                                                                                 minutes).
Focus Group Interviews........           5,897               1           5,897  1.5.............           8,846
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          14,934
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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. 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.

    Dated: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21452 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P


