Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign, 49834-49836 [2017-23450]
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49834
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
As reflected in table 1, we estimate
two manufacturers will submit two
requests annually for tier-one DR, and
that there will be one appeal of these
requests to the DR panel (tier-two DR).
We estimate also that it will take
manufacturers approximately 30 hours
to prepare and submit each request for
a tier-one DR, and approximately 8
hours to prepare and submit each
request for a tier-two DR. Based on our
experience with this collection we have
not changed our estimate since our last
request for OMB approval.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23444 Filed 10–26–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3710]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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.
The Food and Drug
Administration (FDA) 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: Fax written comments on the
collection of information by November
27, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—NEW and
title ‘‘Evaluation of FDA’s Education at
the Point of Sale Campaign.’’ Also,
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
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White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Evaluation of FDA’s Education at the
Point of Sale Campaign OMB Control
Number 0910—NEW
The 2009 Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) amends
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, tobaccorelated attitudes, beliefs and risk
perceptions, and motivation to quit
smoking.
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 tobaccorelated attitudes, beliefs and risk
perceptions, intentions to use tobacco,
and motivation to quit smoking.
Participation in the outcome evaluation
study will be voluntary. All of the
information collected is integral to that
evaluation.
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Sfmt 4703
Evaluation of the Point of Sale
Campaign. This outcome evaluation
study will consist of four longitudinal
data collection periods over 24 months
(approximately every 7 months), with
the first survey (Wave 1) occurring
approximately 3 months after campaign
launch. A fourth wave of data collection
has been added to the three proposed in
the 60-day notice because the campaign
has been extended from 18 to 24
months. The additional wave of data
collection is necessary to continue to
assess the impact of the campaign. To
reduce the number of participants
needed to detect the effects of the
campaign on outcomes of interest, the
design of the campaign was changed
from two treatment groups and one
control group to one treatment group
and one control group. The respondent
numbers and burden hours below have
been revised to reflect the four data
collection waves and the change in the
number of treatment groups.
Information will be collected from
adult cigarette 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 6 months over 18
months.
FDA’s media contractor identified 37
potential counties for the campaign.
From this list, FDA’s evaluation
contractor has selected 30 counties to be
included in the evaluation. Of these, 15
counties will receive the intervention
(treatment counties), and 15 counties
will not receive it (control counties).
The number of counties has changed
since the 60-day notice because we
changed the experimental design to
have one treatment group instead of
two, which resulted in needing fewer
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 postal carrier
routes in the 30 selected U.S. counties
to identify households that 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 104,541 households.
We estimate that 27,651 (9,217
annualized respondents) households
will return the 10-minute screener they
received by mail, and 26,258 (8,753
E:\FR\FM\27OCN1.SGM
27OCN1
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
annualized respondents) households
will complete a 10-minute in-person
field screener conducted by trained field
interviewers. Field interviewers will
attempt to conduct field screeners for all
households that return the mail screener
and appear to have one or more eligible
participants in the household, and a
subsample of the households that do not
return the screener. At 10 minutes per
screening, the potential burden hours
for the mail screener are 4,701 hours
(1,567 annualized). At 10 minutes per
screening, the potential burden hours
for the field screener are 4,464 hours
(1,488). The process for locating and
screening participants has been updated
since the 60-day notice to better reflect
the study design.
Accounting for nonresponse, we
estimate that the mail and field
screenings will result in 4,282 (1,427
annualized) adults who meet criteria for
participation and complete the full
Wave 1 questionnaire. The Wave 1
questionnaire will be completed during
an in-person visit to the home,
immediately after the field screening is
completed, assuming the selected
participant is available to complete the
questionnaire at that time. If the
participant is not available at that time,
the interviewer will schedule a time to
return to the household and complete
the evaluation questionnaire in person.
We estimate that the Wave 1
questionnaire will take 40 minutes to
complete, resulting in 2,869 (956
annualized) burden hours. Adjusting for
loss to follow-up between waves, we
anticipate that 3,426 (1,142 annualized)
participants will complete the Wave 2
questionnaire, which will take 40
minutes and result in 2,295 (765
annualized) burden hours, that 2,912
(971 annualized) participants will
complete the Wave 3 questionnaire,
which will take 40 minutes and result
in 1,951 (650 annualized) burden hours,
and that 2,475 (825 annualized)
participants will complete the Wave 4
questionnaire, which will take 40
minutes and result in 1,658 (553
49835
individual by phone. This verification
process has been added to the
information collection request since the
60-day notice to prevent fraudulent data
entry by interviewers.
In addition to the telephone
verification survey, we will also audio
record (with participants’ consent)
interviews with a random sample of
approximately 10 percent of
respondents to the Wave 1
questionnaire and a random 10 percent
of the Waves 2, 3, and 4 respondents
who complete the questionnaire in
person as an additional quality control
measure. These recordings will be used
to measure interviewer compliance with
study procedures and will be destroyed
after they are reviewed. This procedure
does not affect participant burden.
The total burden hours for the mail
and field screeners, four outcome
evaluation questionnaires, three appbased questionnaires, and four
telephone verification questionnaires is
18,773 (6,258 annualized).
In the Federal Register of November
15, 2016 (81 FR 80075), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Two comments were
received; however, only one was PRArelated.
Comment: One comment stated that
requiring or compelling retailers to
display ‘‘anti-smoking or anti-tobacco
advocacy’’ is prohibited under the First
Amendment. If the campaign is deemed
unconstitutional, then there is no need
for the information collection.
Response: The comment
misunderstands how FDA intends to
carry out this public education
campaign. FDA intends to purchase
advertising space from retailers on a
voluntary basis and will not require that
retailers participate in the campaign.
Therefore, the comment raises an issue
that is outside the scope of this
proposed information collection.
FDA estimates the burden of this
collection of information as follows:
annualized) burden hours. The Waves 2,
3, and 4 questionnaires will be
completed online or in person by
trained interviewers, depending on
participant preference. The total burden
hours for Waves 2 to 4 evaluation
questionnaires will be 5,904 (1,968
annualized).
We anticipate that approximately 54
percent of the participants (2,308 people
(769 annualized)) who complete the
Wave 1 questionnaire will download a
smartphone application that will deliver
brief app-based questionnaires to them
in between the four waves of evaluation
data collection. These participants will
complete three questionnaires lasting 5
minutes each (every 6 months over the
course of 18 months), resulting in 554
(185 annualized) burden hours. The app
will also use geolocation technology to
record participants’ visits to
convenience stores as a measure of
passive campaign exposure.
In addition, over the course of the
study, telephone verification
questionnaires will be conducted with a
small portion of participants. The
purpose of these questionnaires is to
ensure that information obtained by
field interviewers is correct, to evaluate
the performance of field interviewers, to
avoid fraud, and to ensure that all
relevant incentives were delivered.
Trained staff will administer a 5-minute
verification questionnaire to a random
sample of 10 percent of participants
who completed the in-person screening
but not the Wave 1 questionnaire (2,198
individuals (733 annualized)), and a
random sample of 10 percent of
participants who completed the Waves
1 to 4 questionnaires (1,308 individuals
(436 annualized)). At 5 minutes per
verification questionnaire, this results in
177 burden hours (59 annualized) for
the field screener telephone
verifications and 105 burden hours (35
annualized) for the four evaluation
questionnaire telephone verifications.
Some telephone verification
questionnaires may be administered in
person if it is not possible to reach the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Type of respondent
Activity
Households (adults 18 and up) ......
Study participants (opt in) ..............
Mail screener ................................................
Field screener ..............................................
Telephone verification, field screener ..........
Wave 1 questionnaire ..................................
Wave 2–4 questionnaires ............................
Telephone verification, questionnaires 1–4
App-based questionnaire .............................
9,217
8,753
733
1,427
2,938
436
769
1
1
1
1
1
1
3
9,217
8,753
733
1,427
2,938
436
2,308
Total ........................................
.......................................................................
....................
....................
....................
Adult smokers, ages 25 to 54 ........
1 There
Average burden
per response
0.17
0.17
0.08
0.67
0.67
0.08
0.08
(10 minutes) ......
(10 minutes) ......
(5 minutes) ........
(40 minutes) ......
(40 minutes) ......
(5 minutes) ........
(5 minutes) ........
1,567
1,488
59
956
1,968
35
185
....................................
6,258
are no capital costs or operating and maintenance costs associated with this collection of information.
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E:\FR\FM\27OCN1.SGM
Total hours
27OCN1
49836
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23450 Filed 10–26–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6145]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Dispute Resolution
Procedures for Science-Based
Decisions on Products Regulated by
the Center for Veterinary Medicine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 information
collection provisions of the dispute
resolution procedures for science-based
decisions on products regulated by the
Center for Veterinary Medicine (CVM).
DATES: Submit either electronic or
written comments on the collection of
information by December 26, 2017.
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 December 26,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of December 26, 2017.
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.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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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–
2017–N–6145 for ‘‘Dispute Resolution
Procedures for Science-Based Decisions
on Products Regulated by the Center for
Veterinary Medicine.’’ 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
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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: 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. 3501–3520), 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
E:\FR\FM\27OCN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49834-49836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23450]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3710]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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: Fax written comments on the collection of information by
November 27, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910--NEW and
title ``Evaluation of FDA's Education at the Point of Sale Campaign.''
Also, include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Evaluation of FDA's Education at the Point of Sale Campaign OMB Control
Number 0910--NEW
The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) amends 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, tobacco-related attitudes, beliefs
and risk perceptions, and motivation to quit smoking.
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
tobacco-related attitudes, beliefs and risk perceptions, intentions to
use tobacco, and motivation to quit smoking. Participation in the
outcome evaluation study will be voluntary. All of the information
collected is integral to that evaluation.
Evaluation of the Point of Sale Campaign. This outcome evaluation
study will consist of four longitudinal data collection periods over 24
months (approximately every 7 months), with the first survey (Wave 1)
occurring approximately 3 months after campaign launch. A fourth wave
of data collection has been added to the three proposed in the 60-day
notice because the campaign has been extended from 18 to 24 months. The
additional wave of data collection is necessary to continue to assess
the impact of the campaign. To reduce the number of participants needed
to detect the effects of the campaign on outcomes of interest, the
design of the campaign was changed from two treatment groups and one
control group to one treatment group and one control group. The
respondent numbers and burden hours below have been revised to reflect
the four data collection waves and the change in the number of
treatment groups.
Information will be collected from adult cigarette 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 6 months over 18 months.
FDA's media contractor identified 37 potential counties for the
campaign. From this list, FDA's evaluation contractor has selected 30
counties to be included in the evaluation. Of these, 15 counties will
receive the intervention (treatment counties), and 15 counties will not
receive it (control counties). The number of counties has changed since
the 60-day notice because we changed the experimental design to have
one treatment group instead of two, which resulted in needing fewer
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 postal carrier routes in the 30 selected U.S.
counties to identify households that 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 104,541 households. We estimate
that 27,651 (9,217 annualized respondents) households will return the
10-minute screener they received by mail, and 26,258 (8,753
[[Page 49835]]
annualized respondents) households will complete a 10-minute in-person
field screener conducted by trained field interviewers. Field
interviewers will attempt to conduct field screeners for all households
that return the mail screener and appear to have one or more eligible
participants in the household, and a subsample of the households that
do not return the screener. At 10 minutes per screening, the potential
burden hours for the mail screener are 4,701 hours (1,567 annualized).
At 10 minutes per screening, the potential burden hours for the field
screener are 4,464 hours (1,488). The process for locating and
screening participants has been updated since the 60-day notice to
better reflect the study design.
Accounting for nonresponse, we estimate that the mail and field
screenings will result in 4,282 (1,427 annualized) adults who meet
criteria for participation and complete the full Wave 1 questionnaire.
The Wave 1 questionnaire will be completed during an in-person visit to
the home, immediately after the field screening is completed, assuming
the selected participant is available to complete the questionnaire at
that time. If the participant is not available at that time, the
interviewer will schedule a time to return to the household and
complete the evaluation questionnaire in person. We estimate that the
Wave 1 questionnaire will take 40 minutes to complete, resulting in
2,869 (956 annualized) burden hours. Adjusting for loss to follow-up
between waves, we anticipate that 3,426 (1,142 annualized) participants
will complete the Wave 2 questionnaire, which will take 40 minutes and
result in 2,295 (765 annualized) burden hours, that 2,912 (971
annualized) participants will complete the Wave 3 questionnaire, which
will take 40 minutes and result in 1,951 (650 annualized) burden hours,
and that 2,475 (825 annualized) participants will complete the Wave 4
questionnaire, which will take 40 minutes and result in 1,658 (553
annualized) burden hours. The Waves 2, 3, and 4 questionnaires will be
completed online or in person by trained interviewers, depending on
participant preference. The total burden hours for Waves 2 to 4
evaluation questionnaires will be 5,904 (1,968 annualized).
We anticipate that approximately 54 percent of the participants
(2,308 people (769 annualized)) who complete the Wave 1 questionnaire
will download a smartphone application that will deliver brief app-
based questionnaires to them in between the four waves of evaluation
data collection. These participants will complete three questionnaires
lasting 5 minutes each (every 6 months over the course of 18 months),
resulting in 554 (185 annualized) burden hours. The app will also use
geolocation technology to record participants' visits to convenience
stores as a measure of passive campaign exposure.
In addition, over the course of the study, telephone verification
questionnaires will be conducted with a small portion of participants.
The purpose of these questionnaires is to ensure that information
obtained by field interviewers is correct, to evaluate the performance
of field interviewers, to avoid fraud, and to ensure that all relevant
incentives were delivered. Trained staff will administer a 5-minute
verification questionnaire to a random sample of 10 percent of
participants who completed the in-person screening but not the Wave 1
questionnaire (2,198 individuals (733 annualized)), and a random sample
of 10 percent of participants who completed the Waves 1 to 4
questionnaires (1,308 individuals (436 annualized)). At 5 minutes per
verification questionnaire, this results in 177 burden hours (59
annualized) for the field screener telephone verifications and 105
burden hours (35 annualized) for the four evaluation questionnaire
telephone verifications. Some telephone verification questionnaires may
be administered in person if it is not possible to reach the individual
by phone. This verification process has been added to the information
collection request since the 60-day notice to prevent fraudulent data
entry by interviewers.
In addition to the telephone verification survey, we will also
audio record (with participants' consent) interviews with a random
sample of approximately 10 percent of respondents to the Wave 1
questionnaire and a random 10 percent of the Waves 2, 3, and 4
respondents who complete the questionnaire in person as an additional
quality control measure. These recordings will be used to measure
interviewer compliance with study procedures and will be destroyed
after they are reviewed. This procedure does not affect participant
burden.
The total burden hours for the mail and field screeners, four
outcome evaluation questionnaires, three app-based questionnaires, and
four telephone verification questionnaires is 18,773 (6,258
annualized).
In the Federal Register of November 15, 2016 (81 FR 80075), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received; however, only
one was PRA-related.
Comment: One comment stated that requiring or compelling retailers
to display ``anti-smoking or anti-tobacco advocacy'' is prohibited
under the First Amendment. If the campaign is deemed unconstitutional,
then there is no need for the information collection.
Response: The comment misunderstands how FDA intends to carry out
this public education campaign. FDA intends to purchase advertising
space from retailers on a voluntary basis and will not require that
retailers participate in the campaign. Therefore, the comment raises an
issue that is outside the scope of this proposed information
collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total
Type of respondent Activity respondents per annual Average burden per response Total hours
respondent responses
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Households (adults 18 and up)......... Mail screener............ 9,217 1 9,217 0.17 (10 minutes)................ 1,567
Field screener........... 8,753 1 8,753 0.17 (10 minutes)................ 1,488
Telephone verification, 733 1 733 0.08 (5 minutes)................. 59
field screener.
Adult smokers, ages 25 to 54.......... Wave 1 questionnaire..... 1,427 1 1,427 0.67 (40 minutes)................ 956
Wave 2-4 questionnaires.. 2,938 1 2,938 0.67 (40 minutes)................ 1,968
Telephone verification, 436 1 436 0.08 (5 minutes)................. 35
questionnaires 1-4.
Study participants (opt in)........... App-based questionnaire.. 769 3 2,308 0.08 (5 minutes)................. 185
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Total............................. ......................... ........... ........... ........... ................................. 6,258
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 49836]]
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23450 Filed 10-26-17; 8:45 am]
BILLING CODE 4164-01-P
