[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12952-12954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0180]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Generic Clearance for the Collection of Quantitative 
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 the generic clearance for the collection of 
quantitative data on tobacco products and communications.

DATES: Submit either electronic or written comments on the collection 
of information by May 4, 2021.

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 May 4, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 4, 2021. 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:
    <bullet> 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.
    <bullet> 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'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> 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.
    <bullet> 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-2018-N-0180 for ``Generic Clearance for the Collection of 
Quantitative 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.
    <bullet> 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

[[Page 12953]]

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, 
<a href="/cdn-cgi/l/email-protection#0f5f5d4e5c7b6e69694f696b6e2167677c21686079"><span class="__cf_email__" data-cfemail="5d0d0f1c0e293c3b3b1d3b393c7335352e733a322b">[email protected]</span></a>.

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 Quantitative Data on Tobacco 
Products and Communications

OMB Control Number 0910-0810--Extension

    To conduct educational and public information programs relating to 
tobacco use as authorized by section 1003(d)(2)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA's Center for 
Tobacco Products will conduct research and use a variety of media to 
inform and educate the public, tobacco retailers, and health 
professionals about the health risks of tobacco use, how to quit using 
tobacco products, and FDA's role in regulating tobacco.
    To ensure that these educational and public information programs 
have the highest potential to be received, understood, and accepted by 
those for whom they are intended, the Center for Tobacco Products will 
conduct research and develop health messages relating to the control 
and prevention of disease. In conducting such research, FDA will use 
quantitative methods (i.e., surveys, experimental studies) for studies 
about tobacco products. These studies may be used to collect 
information related to the formative pretesting of tobacco 
communication messages and other materials directed at consumers. This 
type of research involves: (1) Assessing audience knowledge, attitudes, 
behaviors, and other characteristics for the purpose of determining the 
need for and developing health messages, communication strategies, and 
public information programs; (2) pretesting these health messages, 
strategies, and program components while they are in developmental form 
to assess audience comprehension, reactions, and perceptions; and (3) 
adding to the regulatory science knowledge base. Quantitative studies 
play an important role in exploring areas of research and gathering 
information because they can be used to summarize a population of 
interest on key variables or reveal systematic relationships between 
variables.
    Formative pretesting is a staple of best practices in 
communications research. Obtaining voluntary feedback from intended 
audiences during the development of messages and materials is crucial 
for the success of every communication program. The purpose of 
obtaining information from formative pretesting is that it allows FDA 
to improve materials and strategies while revisions are still 
affordable and possible. Formative pretesting can also avoid 
potentially expensive and dangerous unintended outcomes caused by 
audiences interpreting messages in a way that was not intended by the 
drafters. By maximizing the effectiveness of messages and strategies 
for reaching targeted audiences, the frequency with which tobacco 
communication messages need to be modified should be greatly reduced.
    The voluntary information collected will serve the primary purpose 
of providing FDA information about the perceived effectiveness of 
messages, advertisements, and materials in reaching and successfully 
communicating with their intended audiences. Quantitative testing 
messages and other materials with a sample of the target audience will 
allow FDA to refine messages, advertisements, and materials, including 
questionnaires or images, directed at consumers while the materials are 
still in the developmental stage.
    In addition, quantitative information is needed by FDA to track 
changes in response to policy and regulatory actions and to expand the 
tobacco regulatory science base by providing information on behavior, 
knowledge, and attitudes about tobacco products, including 
postmarketing surveillance of tobacco products.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 12954]]



                                                      Table 1--Estimated Annual Reporting Burden 1
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                                                              Number  of
                 Activity                     Number  of     responses per   Total annual           Average burden  per response            Total hours
                                              respondents     respondent       responses
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Screener..................................         485,580               1         485,580  0.083 (5 minutes)...........................          40,465
Self-Administered Surveys.................         133,728               1         133,728  0.33 (20 minutes)...........................          44,576
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................................          85,041
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Number of respondents to be included in each new survey will vary, 
depending on the nature of the material or message being tested and the 
target audience. Table 1 provides examples of the types of activities 
that may be administered and estimated burden levels during the 3-year 
period. Time to read, review, or complete the activity is built into 
the ``Average Burden per Response'' figures. Our estimated burden for 
the information collection reflects an overall increase of 60,000 hours 
and a corresponding increase of 461,808 responses. We attribute the 
adjustment to an increase in the number of new quantitative studies 
that are anticipated underneath this information collection during the 
next 3 years (proposed extension).

    Dated: March 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04606 Filed 3-4-21; 8:45 am]
BILLING CODE 4164-01-P


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