[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Pages 6190-6192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02852]


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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 ``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 April 16, 2018.

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 April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 16, 2018. 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'').

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-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.
     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

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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.gpo.gov/fdsys/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.

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: Under the PRA (44 U.S.C. 3501-3520), 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

    In order 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 create and use a variety of media to 
inform and educate the public, tobacco retailers, and health 
professionals about the risks of tobacco use, how to quit using tobacco 
products, and FDA's role in regulating tobacco.
    To ensure that these health communication messages 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 studies relating to the control and prevention of disease. 
In conducting such research, FDA will employ formative pretests. 
Formative pretests are conducted on a small scale, and their focus is 
on developing and assessing the likely effectiveness of communications 
with specific target audiences. 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 and (2) pretesting these health messages, 
strategies, and program components while they are in developmental form 
to assess audience comprehension, reactions, and perceptions.
    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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     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....................................         130,500               1         130,500  0.083 (5 minutes).........................          10,831
Self-Administered Surveys...................          27,000               1          27,000  0.33 (20 minutes).........................           8,910
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    Total...................................  ..............  ..............  ..............  ..........................................          19,741
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 6192]]

    The 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. The burden for this information collection 
extension is proposed to increase by 12,613 hours since the last OMB 
approval. The burden increase is due to an increase in the number of 
respondents and the categories of respondents.

    Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02852 Filed 2-12-18; 8:45 am]
 BILLING CODE 4164-01-P