Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco Among the Lesbian Gay Bisexual Transgender Community, 37817-37819 [2018-16538]
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Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices
FDA receives reports through the
MedWatch website (https://
www.fda.gov/Safety/MedWatch/
HowToReport/default.htm), which are
then entered into the FDA Adverse
Event Reporting System for subsequent
analysis. Because the volume of reports
is large and because reporting entities
(product manufacturers and the
professional or lay public) need only
suspect a possible link between product
exposure and an adverse event, FDA
employs specific tools and strategies to
assess postmarket safety reports and
potential signals that arise from review
of these reports. The process for receipt
and assessment of such postmarket
safety information is referred to as
pharmacovigilance.
FDA has a specific regulatory
mandate to perform pediatric
pharmacovigilance and to present or
make available the results of such
pediatric pharmacovigilance to the
Pediatric Advisory Committee.
II. Topics for Discussion at the Public
Workshop
daltland on DSKBBV9HB2PROD with NOTICES
III. Participation in the Public
Workshop
Jkt 244001
[FR Doc. 2018–16524 Filed 8–1–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2015–N–2126]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration’s Research and
Evaluation Survey for the Public
Education Campaign on Tobacco
Among the Lesbian Gay Bisexual
Transgender Community
AGENCY:
Food and Drug Administration,
HHS.
Registration: Persons interested in
attending this public workshop must
register online at https://
www.eventbrite.com/e/advancing-thedevelopment-of-pediatric-therapeutics5-adept5-tickets-46654530958 by
Thursday, September 6, 2018, midnight
Eastern Time. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone. Onsite
registration will not be available.
Registration for onsite participation or
via webcast is free and based on space
availability, with priority given to early
registrants. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted.
If you need special accommodations
due to a disability, please contact
Denise Pica-Branco (denise.picabranco@
fda.hhs.gov) or Meshaun Payne
(meshaun.payne@fda.hhs.gov) no later
than Thursday, September 6, 2018.
17:06 Aug 01, 2018
Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
In this workshop, FDA will gather
information on the latest developments
in pediatric pharmacovigilance from the
perspective of various stakeholders and
expand the conversation to include the
utility and challenges of emerging
pharmacovigilance tools, including
specific challenges associated with
pediatric data tools.
VerDate Sep<11>2014
Streaming Webcast of the Public
Workshop: Webcast information will be
provided after participants have
registered for the workshop. If you have
never attended a Connect Pro event
before, test your connection at https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. To get a
quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview.
FDA has verified the website
addresses in this document, as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
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 FDA’s Research
and Evaluation Survey for the Public
Education Campaign on Tobacco
(RESPECT) among the Lesbian Gay
Bisexual Transgender (LGBT).
DATES: Submit either electronic or
written comments on the collection of
information by October 1, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
SUMMARY:
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37817
be submitted on or before October 1,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 1, 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–
2015–N–2126 for ‘‘Food and Drug
Administration’s (FDA’s) Research and
Evaluation Survey for the Public
Education Campaign on Tobacco
(RESPECT) among LGBT.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
E:\FR\FM\02AUN1.SGM
02AUN1
daltland on DSKBBV9HB2PROD with NOTICES
37818
Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices
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
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:
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, 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
VerDate Sep<11>2014
17:06 Aug 01, 2018
Jkt 244001
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.
Food and Drug Administration’s
(FDA’s) Research and Evaluation
Survey for the Public Education
Campaign on Tobacco (RESPECT)
Among LGBT
OMB Control Number 0910–0808–
Extension
The 2009 Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) amended
the Federal Food, Drug, and Cosmetic
Act (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. In May 2016,
FDA began implementing a public
education campaign to help prevent and
reduce tobacco use among LGBT young
adults and thereby reduce the public
health burden of tobacco. The campaign
continues to be implemented in 12 U.S.
cities and features events, television and
radio and print advertisements, digital
communications, including videos,
social media, and other forms of media.
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For the purpose of this notice, these
campaign elements will be referred to as
‘‘advertisements’’ or ‘‘ads.’’
In support of the provisions of the
Tobacco Control Act that require FDA to
protect the public health and to reduce
tobacco use, FDA requests OMB
approval to collect information needed
to evaluate FDA’s campaign to reduce
tobacco use among LGBT young adults.
Comprehensive evaluation of FDA’s
public education campaigns is needed
to ensure campaign messages are
effectively received, understood, and
accepted by those for whom they are
intended. Evaluation is an essential
organizational practice in public health
and a systematic way to account for and
improve public health actions.
To evaluate the effectiveness of FDA’s
RESPECT at reducing tobacco use
among LGBT young adults aged 18 to
24, FDA contracted with RTI
International (RTI) to conduct Webbased surveys with the target population
in the 12 campaign cities and 12
comparison cities. The surveys include
measures of tobacco-related knowledge,
attitudes, beliefs, intentions, and use as
well as measures of audience awareness
of and exposure to campaign events and
advertisements. The voluntary surveys
also collect information on demographic
variables, including sexual orientation,
age, sex, race/ethnicity, education, and
primary language. Baseline data
collection for RESPECT was conducted
between February and May 2016. Four
subsequent waves of data collection
were conducted with new (crosssectional) and returning (longitudinal)
respondents. This design facilitated
analysis of relationships between
individuals’ exposure to campaign
activities and baseline to follow-up
changes in outcomes of interest between
campaign and comparison cities.
Information collection for baseline and
the first four follow-ups was reviewed
and approved by OMB.
FDA will continue to implement
RESPECT in 12 U.S. cities through April
2019. To complete the evaluation of
RESPECT, FDA is requesting an
extension of the previously approved
information collection in order to
conduct two additional waves of data
collection with the target population.
The proposed sixth and seventh waves
of data collection (i.e., fifth and sixth
follow-ups after baseline) will coincide
with the official end of the campaign,
and will serve as an assessment of the
campaign at completion. Continued
evaluation is necessary in order to
determine the campaign’s impact on
outcomes of interest.
As in previous waves, new and
returning survey respondents will be
E:\FR\FM\02AUN1.SGM
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Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices
invited to complete the online
questionnaire. New (or cross-sectional)
respondents will be recruited at LGBT
social venues and via social media (i.e.,
Facebook and Twitter). In-person
recruitment will take place in a variety
of LGBT venues. The owners or
managers of potential recruitment sites
will be asked a series of questions to
determine the appropriateness of its
clientele for participation in the study.
For the fifth and sixth follow-ups, an
estimated 60 new venues (20
annualized) will be assessed at 5
minutes per assessment, for an
additional 5 hours (1.67 annualized). A
total of 1,980 venues (660 annualized)
will be assessed during the evaluation
study, for a total of 165 hours (55
annualized).
Our goal is to recruit 75 percent of the
sample via intercept interviews and 25
percent via social media. To obtain the
target number of completed fifth and
sixth follow-up questionnaires, an
additional 11,904 adults (3,968
annualized) recruited in person and
2,736 adults (912 annualized) recruited
via social media will complete
screening questionnaires. For the entire
evaluation study, a total of 33,717 adults
(11,239 annualized) recruited in person
will complete screening questionnaires
along with 10,617 adults (3,539
annualized) recruited via social media.
The estimated burden to complete the
screening questionnaire is 5 minutes
(0.083 hour), for a total of 2,799 hours
(933 annualized) for in-person recruits
and 881 hours (294 annualized) for
social media recruits.
Based on analysis of response rates
from prior waves of data collection, we
expect 65 percent of intercept
respondents will be deemed eligible and
50 percent of those will complete the
fifth follow-up questionnaire. We expect
30 percent of those recruited via social
media will be deemed eligible and
complete the fifth follow-up
questionnaire. Lastly, we expect 50
percent of returning (or longitudinal)
respondents to complete the fifth and
sixth follow-up questionnaires. We
estimate that approximately 2,100 new
respondents (700 annualized) and 6,678
returning (2,226 annualized)
respondents will complete the fifth and
sixth follow-up questionnaires, for a
total of 8,778 responses (2,926
annualized).
OMB previously approved 3,156
(1,052 annualized) respondents
recruited via social media and 9,456
(3,152 annualized) respondents
recruited in person to complete the first
four follow-up questionnaires. Adding
the fifth and sixth follow-ups brings the
37819
total estimated number of follow up
questionnaires completed by social
media recruits to 5,256 (1,752
annualized) and by in-person recruits to
16,134 (5,378 annualized). At 40
minutes per completed questionnaire,
the total burden is 3,507 hours (1,169
annualized) for social media
respondents and 10,761 hours (3,587
annualized) for in-person respondents.
OMB also previously approved 393
hours (approximately 132 annualized)
for social media respondents and 1,182
hours (394 annualized) for in-person
respondents to complete baseline
questionnaires. OMB also approved the
pilot test of procedures in bars (6 hours
[2 annualized]). As these study
components are complete, the
corresponding burden will not change.
Lastly, the original study design
included a media tracking component,
which included a burden of 414 hours
(138 annualized) for completing a 5minute screening questionnaire and 999
hours (333 annualized) for completing
the media tracking questionnaire.
However, this component was dropped
from the study; hence, the related
burden has been deducted from the total
study burden.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Respondent type and activity
Venue Owners and Managers ..............................
General Population: Pilot test of Procedures in
Bars.
General population—outcome screener (in person).
General population—outcome screener (social
media).
LGBT young adults outcome baseline (social
media).
LGBT young adults outcome baseline (in person)
LGBT young adults outcome follow-up questionnaire (social media).
LGBT young adults outcome follow-up questionnaire (in person).
Totals .............................................................
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1 There
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
660
27
1
1
660
27
0.083 (5 minutes) .........
0.083 (5 minutes) .........
55
2
11,239
1
11,239
0.083 (5 minutes) .........
933
3,539
1
3,539
0.083 (5 minutes) .........
294
263
1
263
0.500 (30 minutes) .......
132
788
1,752
1
1
788
1,752
0.500 (30 minutes) .......
0.667 (40 minutes) .......
394
1,169
5,378
1
5,378
0.667 (40 minutes) .......
3,587
........................
.......................................
6,566
........................
........................
are no capital costs or operating and maintenance costs associated with this collection of information.
To accommodate the additional waves
of data collection, FDA requests
approval to increase the number of
burden hours under the existing control
number. The previous number of
approved responses was 53,967 (17,989
annualized), and the previous burden
was 14,031 hours (4,677 annualized).
The fifth and sixth follow-ups add
23,478 responses (7,826 annualized),
VerDate Sep<11>2014
17:06 Aug 01, 2018
Jkt 244001
which include responses to new venues
assessments, screening questionnaires,
and the follow-up questionnaires, for a
total of 7,074 additional burden hours
(2,357 annualized). Removing the media
tracking component deducts 6,507
responses (2,169 annualized) and 1,413
burden hours (471 annualized). The
totals for the entire evaluation study are
increasing by 16,971 responses (5,657
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annualized) and 5,661 hours (1,887
annualized) for a new total of 70,938
responses (23,646 annualized) and
19,692 burden hours (approximately
6,566 annualized).
Dated: July 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16538 Filed 8–1–18; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Notices]
[Pages 37817-37819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16538]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2126]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Drug Administration's Research and Evaluation
Survey for the Public Education Campaign on Tobacco Among the Lesbian
Gay Bisexual Transgender Community
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 FDA's Research and Evaluation Survey for
the Public Education Campaign on Tobacco (RESPECT) among the Lesbian
Gay Bisexual Transgender (LGBT).
DATES: Submit either electronic or written comments on the collection
of information by October 1, 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 October 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 1, 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-2015-N-2126 for ``Food and Drug Administration's (FDA's) Research
and Evaluation Survey for the Public Education Campaign on Tobacco
(RESPECT) among LGBT.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those
[[Page 37818]]
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 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.
Food and Drug Administration's (FDA's) Research and Evaluation Survey
for the Public Education Campaign on Tobacco (RESPECT) Among LGBT
OMB Control Number 0910-0808-Extension
The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) amended the Federal Food, Drug, and
Cosmetic Act (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. In May 2016, FDA began implementing a public
education campaign to help prevent and reduce tobacco use among LGBT
young adults and thereby reduce the public health burden of tobacco.
The campaign continues to be implemented in 12 U.S. cities and features
events, television and radio and print advertisements, digital
communications, including videos, social media, and other forms of
media. For the purpose of this notice, these campaign elements will be
referred to as ``advertisements'' or ``ads.''
In support of the provisions of the Tobacco Control Act that
require FDA to protect the public health and to reduce tobacco use, FDA
requests OMB approval to collect information needed to evaluate FDA's
campaign to reduce tobacco use among LGBT young adults. Comprehensive
evaluation of FDA's public education campaigns is needed to ensure
campaign messages are effectively received, understood, and accepted by
those for whom they are intended. Evaluation is an essential
organizational practice in public health and a systematic way to
account for and improve public health actions.
To evaluate the effectiveness of FDA's RESPECT at reducing tobacco
use among LGBT young adults aged 18 to 24, FDA contracted with RTI
International (RTI) to conduct Web-based surveys with the target
population in the 12 campaign cities and 12 comparison cities. The
surveys include measures of tobacco-related knowledge, attitudes,
beliefs, intentions, and use as well as measures of audience awareness
of and exposure to campaign events and advertisements. The voluntary
surveys also collect information on demographic variables, including
sexual orientation, age, sex, race/ethnicity, education, and primary
language. Baseline data collection for RESPECT was conducted between
February and May 2016. Four subsequent waves of data collection were
conducted with new (cross-sectional) and returning (longitudinal)
respondents. This design facilitated analysis of relationships between
individuals' exposure to campaign activities and baseline to follow-up
changes in outcomes of interest between campaign and comparison cities.
Information collection for baseline and the first four follow-ups was
reviewed and approved by OMB.
FDA will continue to implement RESPECT in 12 U.S. cities through
April 2019. To complete the evaluation of RESPECT, FDA is requesting an
extension of the previously approved information collection in order to
conduct two additional waves of data collection with the target
population. The proposed sixth and seventh waves of data collection
(i.e., fifth and sixth follow-ups after baseline) will coincide with
the official end of the campaign, and will serve as an assessment of
the campaign at completion. Continued evaluation is necessary in order
to determine the campaign's impact on outcomes of interest.
As in previous waves, new and returning survey respondents will be
[[Page 37819]]
invited to complete the online questionnaire. New (or cross-sectional)
respondents will be recruited at LGBT social venues and via social
media (i.e., Facebook and Twitter). In-person recruitment will take
place in a variety of LGBT venues. The owners or managers of potential
recruitment sites will be asked a series of questions to determine the
appropriateness of its clientele for participation in the study. For
the fifth and sixth follow-ups, an estimated 60 new venues (20
annualized) will be assessed at 5 minutes per assessment, for an
additional 5 hours (1.67 annualized). A total of 1,980 venues (660
annualized) will be assessed during the evaluation study, for a total
of 165 hours (55 annualized).
Our goal is to recruit 75 percent of the sample via intercept
interviews and 25 percent via social media. To obtain the target number
of completed fifth and sixth follow-up questionnaires, an additional
11,904 adults (3,968 annualized) recruited in person and 2,736 adults
(912 annualized) recruited via social media will complete screening
questionnaires. For the entire evaluation study, a total of 33,717
adults (11,239 annualized) recruited in person will complete screening
questionnaires along with 10,617 adults (3,539 annualized) recruited
via social media. The estimated burden to complete the screening
questionnaire is 5 minutes (0.083 hour), for a total of 2,799 hours
(933 annualized) for in-person recruits and 881 hours (294 annualized)
for social media recruits.
Based on analysis of response rates from prior waves of data
collection, we expect 65 percent of intercept respondents will be
deemed eligible and 50 percent of those will complete the fifth follow-
up questionnaire. We expect 30 percent of those recruited via social
media will be deemed eligible and complete the fifth follow-up
questionnaire. Lastly, we expect 50 percent of returning (or
longitudinal) respondents to complete the fifth and sixth follow-up
questionnaires. We estimate that approximately 2,100 new respondents
(700 annualized) and 6,678 returning (2,226 annualized) respondents
will complete the fifth and sixth follow-up questionnaires, for a total
of 8,778 responses (2,926 annualized).
OMB previously approved 3,156 (1,052 annualized) respondents
recruited via social media and 9,456 (3,152 annualized) respondents
recruited in person to complete the first four follow-up
questionnaires. Adding the fifth and sixth follow-ups brings the total
estimated number of follow up questionnaires completed by social media
recruits to 5,256 (1,752 annualized) and by in-person recruits to
16,134 (5,378 annualized). At 40 minutes per completed questionnaire,
the total burden is 3,507 hours (1,169 annualized) for social media
respondents and 10,761 hours (3,587 annualized) for in-person
respondents.
OMB also previously approved 393 hours (approximately 132
annualized) for social media respondents and 1,182 hours (394
annualized) for in-person respondents to complete baseline
questionnaires. OMB also approved the pilot test of procedures in bars
(6 hours [2 annualized]). As these study components are complete, the
corresponding burden will not change. Lastly, the original study design
included a media tracking component, which included a burden of 414
hours (138 annualized) for completing a 5-minute screening
questionnaire and 999 hours (333 annualized) for completing the media
tracking questionnaire. However, this component was dropped from the
study; hence, the related burden has been deducted from the total study
burden.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of
Respondent type and activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Venue Owners and Managers.... 660 1 660 0.083 (5 55
minutes).
General Population: Pilot 27 1 27 0.083 (5 2
test of Procedures in Bars. minutes).
General population--outcome 11,239 1 11,239 0.083 (5 933
screener (in person). minutes).
General population--outcome 3,539 1 3,539 0.083 (5 294
screener (social media). minutes).
LGBT young adults outcome 263 1 263 0.500 (30 132
baseline (social media). minutes).
LGBT young adults outcome 788 1 788 0.500 (30 394
baseline (in person). minutes).
LGBT young adults outcome 1,752 1 1,752 0.667 (40 1,169
follow-up questionnaire minutes).
(social media).
LGBT young adults outcome 5,378 1 5,378 0.667 (40 3,587
follow-up questionnaire (in minutes).
person).
----------------------------------------------------------------------------------
Totals................... .............. ............... .............. ................ 6,566
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
To accommodate the additional waves of data collection, FDA
requests approval to increase the number of burden hours under the
existing control number. The previous number of approved responses was
53,967 (17,989 annualized), and the previous burden was 14,031 hours
(4,677 annualized). The fifth and sixth follow-ups add 23,478 responses
(7,826 annualized), which include responses to new venues assessments,
screening questionnaires, and the follow-up questionnaires, for a total
of 7,074 additional burden hours (2,357 annualized). Removing the media
tracking component deducts 6,507 responses (2,169 annualized) and 1,413
burden hours (471 annualized). The totals for the entire evaluation
study are increasing by 16,971 responses (5,657 annualized) and 5,661
hours (1,887 annualized) for a new total of 70,938 responses (23,646
annualized) and 19,692 burden hours (approximately 6,566 annualized).
Dated: July 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16538 Filed 8-1-18; 8:45 am]
BILLING CODE 4164-01-P
