[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)]
[Notices]
[Pages 80075-80077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27330]



[[Page 80075]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3710]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Evaluation of the Food and Drug Administration's 
Education at the Point of Sale Campaign

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish a notice in the 
Federal Register concerning each proposed collection of information, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the creation of a cohort of cigarette 
smoking adults between the ages of 25 and 54 for the evaluation of 
FDA's point of sale tobacco education campaign.

DATES: Submit either electronic or written comments on the collection 
of information by January 17, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-N-3710 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Evaluation of the Food and Drug 
Administration's Education at the Point of Sale Campaign.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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 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.
Evaluation of FDA's Point-of-Sale Public Education Campaign
OMB Control Number--0910-NEW
    The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) amends

[[Page 80076]]

the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to grant FDA 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect public health and to reduce tobacco use by 
minors. Section 1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) 
supports the development and implementation of FDA public education 
campaigns related to tobacco use. Accordingly, FDA is currently 
developing and implementing a tobacco education intervention at the 
point of sale to reduce the public health burden of tobacco use. The 
campaign features advertisements intended to encourage future quit 
attempts among current smokers in stores that sell tobacco products.
    In support of the provisions of the Tobacco Control Act that 
require FDA to protect the public health, FDA requests OMB approval to 
collect information to evaluate the effectiveness of the point of sale 
tobacco education campaign. Data from this outcome evaluation study 
will be used to examine statistical associations between exposure to 
the campaign and specific outcomes of interest, which include awareness 
of the campaign and its messaging, campaign-related attitudes, beliefs 
and risk perceptions, motivation to quit smoking, self-efficacy for 
quitting, and increased intention to quit.
    Evaluation is an essential organizational practice in public health 
and a systematic way to account for and improve public health actions. 
Comprehensive evaluation of FDA's public education campaigns will be 
used to document whether the intended audience is aware of and 
understands campaign messages, and whether campaign exposure influences 
campaign-related attitudes, beliefs and risk perceptions, motivation to 
quit smoking, self-efficacy for quitting, and increased intention to 
quit. All of the information collected is integral to that evaluation.
    Evaluation of the Point of Sale Campaign. This outcome evaluation 
study will consist of three longitudinal data collection periods each 
lasting 3-4 months at 4 month intervals between data collection 
periods, with the first survey (Wave 1) occurring 3 months after 
campaign launch. Information will be collected from adult smokers, ages 
25 to 54, about awareness of and exposure to campaign advertisements, 
tobacco use, and knowledge, attitudes, and beliefs related to tobacco 
use. Information will be collected on demographic variables including 
age, sex, race/ethnicity, and primary language. Participants will also 
be offered the option to download a smartphone application that will 
track their exposure to the campaign, and that will ask them to respond 
to a brief survey about every six months over the 18 month study 
period.
    FDA's media contractor has identified 52 potential counties for the 
campaign. From this list, FDA's evaluation contractor will randomly 
select 36 counties to be included in the evaluation. Of these, 24 
counties will receive the intervention, while 12 counties will not 
receive it (control counties).
    Data will be collected from a longitudinal cohort that will consist 
of an entirely new sample of adult cigarette smokers. Addresses will be 
randomly selected from a predetermined list of U.S. counties and merged 
with household data on age and demographic characteristics commonly 
associated with smoking status in order to identify households that are 
likely to contain one or more adult smokers between the ages of 25 and 
54. Pre-paid pre-addressed paper screening surveys will be mailed to 
approximately 71,875 (23,958 annualized) households that meet this 
criteria. For the purpose of calculating maximum burden, we assume that 
all 71,875 (23,958 annualized) households will be screened in one of 
two ways: (1) When an adult member of the household completes and 
returns the 10-minute screener they received by mail, or (2) during a 
10 minute in-person screening interview conducted by trained field 
interviewers who visit all the addresses that do not return the 
screener. At 10 minutes per screening, the maximum potential burden 
hours for the mail screener is 12,219 (4,073 annualized).
    Accounting for nonresponse, we estimate that the mail and in-person 
screenings will result in 5,750 (1,917 annualized) adults who meet 
criteria for participation and complete the full Wave 1 survey. The 
Wave 1 survey will be completed during an in-person visit to the home, 
either as a stand-alone visit (for households that returned the mail 
screener) or immediately after the in-person screening is completed 
(for households that did not return the mail screener). We estimate 
that the Wave 1 survey will take 40 minutes to complete, resulting in 
3,853 (1,284 annualized) burden hours. Adjusting for loss to follow-up 
between waves, we anticipate that 4,600 (1,533 annualized) participants 
will complete the Wave 2 survey, which will take 40 minutes and result 
in 3,082 (1,027 annualized) burden hours, and that 3,772 (1,257 
annualized) participants will complete the Wave 3 survey, which will 
take 40 minutes and result in 2,527 (842 annualized) burden hours. Both 
the Wave 2 and 3 surveys will also be administered in person by trained 
interviewers. The total burden hours for all three in-person surveys 
will be 9,462 (3,154 annualized).
    We anticipate that approximately \2/3\ of the participants (3,833 
people [1,278 annualized]) who complete the Wave 1 survey will download 
a smartphone application that will deliver additional surveys to them 
starting one month after the end of the first data collection. These 
participants will complete 3 surveys lasting 5 minutes each (every 6 
months over the course of 18 months), resulting in 307 (102 annualized) 
burden hours per app-based survey and 921 (307 annualized) burden hours 
total for all of the app-based surveys. The total burden hours for the 
screener, 3 in-person surveys, and 3 app-based surveys is 22,600 (7,533 
annualized).

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         No. of         Total
           Type of respondent                       Activity               No. of     responses per     annual    Average burden per response    Total
                                                                        respondents    respondent     responses                                  hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Households..............................  Screener....................       23,958               1       23,958  0.17 (10 minutes)..........      4,073
Adults smokers ages 25 to 54............  Wave 1 questionnaire                1,917               1        1,917  0.67 (40 minutes)..........      1,284
                                           (Current smokers).
                                          Wave 2 questionnaire........        1,533               1        1,533  0.67 (40 minutes)..........      1,027
                                          Wave 3 questionnaire........        1,257               1        1,257  0.67 (40 minutes)..........        842
Study participants (opt in).............  App-based survey............        1,278               3        3,834  0.08 (5 minutes)...........        307
    Totals..............................  ............................  ...........  ..............       32,499  ...........................      7,533
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 80077]]

    Dated: November 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27330 Filed 11-14-16; 8:45 am]
BILLING CODE 4164-01-P