Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's `Fresh Empire' Multicultural Youth Tobacco Prevention Campaign, 61003-61006 [2017-27712]
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Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
February 26, 2018.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lllll , Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–1696 Appointment of
Representative
CMS–10536 Medicaid Eligibility and
Enrollment (EE) Implementation
Advanced Planning Document
(IAPD) Template
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61003
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.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Dated: December 20, 2017.
William N. Parham, III
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Appointment of
Representative; Use: The Appointment
of Representative form is completed by
beneficiaries, providers and suppliers,
and any party seeking to appoint a
representative to assist them with their
initial determinations and filing
appeals. Form Number: CMS–1696
(OMB control number: 0938–0950);
Frequency: Once; Affected Public:
Individuals and Households, and the
Private sector (Business or other forprofits); Number of Respondents:
3,472,840; Total Annual Responses:
347,284; Total Annual Hours: 86,821.
(For policy questions regarding this
collection contact Katherine Hosna at
410–786–4993.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid
Eligibility and Enrollment (EE)
Implementation Advanced Planning
Document (IAPD) Template; Use: To
assess the appropriateness of states’
requests for enhanced federal financial
participation for expenditures related to
Medicaid eligibility determination
systems, we will review the submitted
information and documentation to make
an approval determination for the
advanced planning document. Form
Number: CMS–10536 (OMB control
number: 0938–1268); Frequency: Yearly,
once, and occasionally; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 56; Total
Annual Responses: 168; Total Annual
Hours: 2,688. (For policy questions
regarding this collection contact Martin
Rice at 410–786–2417.)
AGENCY:
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[FR Doc. 2017–27787 Filed 12–22–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2294]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Evaluation of the
Food and Drug Administration’s ‘Fresh
Empire’ Multicultural Youth Tobacco
Prevention Campaign
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 an extension of
the time period for the outcome
evaluation of FDA’s multicultural youth
tobacco public education campaign, the
addition of two rounds of data
collection with the original youth
surveyed for the outcome evaluation,
and recruitment of new youth to
participate in those two additional
surveys.
DATES: Submit either electronic or
written comments on the collection of
information by February 26, 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 February 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 26, 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.
SUMMARY:
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Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices
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’’).
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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–
2014–N–2294 for ‘‘Evaluation of the
Food and Drug Administration’s ‘Fresh
Empire’ Multicultural Youth Tobacco
Prevention Campaign’’ 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
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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
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
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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 the Food and Drug
Administration’s ‘Fresh Empire’
Multicultural Youth Tobacco
Prevention Campaign (OMB Control
Number 0910–0788—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 (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 youth-targeted public
education campaign (‘Fresh Empire’) to
help prevent tobacco use among
multicultural youth and thereby reduce
the public health burden of tobacco. The
campaign features events,
advertisements on television and radio
and in print, digital communications
including social media, and other forms
of media.
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
multicultural public education
campaign will be used to document
whether the intended audience is aware
of and understands campaign messages,
and whether campaign exposure
influences specific cognitive outcomes
related to tobacco use that are targeted
by the campaign.
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FDA is in the process of evaluating
the effectiveness of its multicultural
youth tobacco prevention campaign
through an outcome evaluation study
that follows the multiple, discrete waves
of media advertising planned for the
campaign. All information collected is
integral to that evaluation.
FDA’s Fresh Empire youth tobacco
public education campaign aims to
reduce tobacco use among youth who
affiliate with a hip-hop peer crowd,
predominantly among African
American, Hispanic, and Asian/Pacific
Islander youth. The outcome evaluation
of the campaign consists of a pre-test
survey of youth aged 12 to 17 before
campaign launch followed by a series of
post-test surveys beginning
approximately 6 months after the
campaign launch. The post-test surveys
are conducted among youth who
participated in one or more surveys (the
embedded longitudinal cohort) and new
participants who are recruited to make
up for attrition. Eligible youth were
initially 12- to 17-year-old youth who
are influenced by the hip-hop peer
crowd. Youth in the embedded
longitudinal cohort may reach the age of
18 over the course of the evaluation.
To date, the pre-test and two post-test
surveys have been conducted. A third
post-test survey is currently underway.
Information has been collected about
youth awareness of and exposure to
campaign events and advertisements
and about tobacco-related knowledge,
attitudes, beliefs, intentions, and use.
Information has also been collected on
demographic variables including age,
sex, race/ethnicity, grade level, and
primary language.
All information is being collected
through in-person and web-based
questionnaires. Youth respondents were
recruited from two sources: (1) A
sample drawn from 30 U.S. media
markets gathered using an addressbased postal mail sampling of U.S.
households for the outcome evaluation,
and (2) targeted social media (e.g.,
Facebook).
This study is being conducted in
support of the provisions of the Tobacco
Control Act that require FDA to protect
the public health and to educate the
population about the risks and potential
risks of tobacco use. The information
being collected is necessary to inform
FDA’s efforts towards these goals and to
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measure the effectiveness and public
health impact of the campaign. Data
from the outcome evaluation are being
used to estimate awareness of and
exposure to the campaign among youth
in target markets where the campaign is
active. Data are also being used to
examine statistical associations between
exposure to the campaign and
subsequent changes in specific
outcomes of interest, which include
knowledge, attitudes, and beliefs related
to tobacco use.
FDA requests OMB approval to
extend OMB approval of the evaluation
of FDA’s multicultural youth tobacco
public education campaign and to add
two additional waves of data collection
with existing youth in the study. To
accommodate these two additional
surveys, FDA requests approval to
increase the number of burden hours
under the existing control number. The
fourth post-test survey will begin in July
2018. The fifth post-test survey will
begin in February 2019. As was done in
earlier post-test surveys, new youth will
be recruited to participate to make up
for attrition.
A total of 2,100 youth will complete
questionnaires for the fourth post-test
survey, and the same number will
complete questionnaires for the fifth
post-test survey. These respondents will
include existing youth who have
participated in one or more surveys
previously (‘‘Longitudinal Cohort’’) and
new youth recruited via a mail-based
screener or social media ads (‘‘CrossSectional Refresher Sample’’). Based on
earlier response rates and longitudinal
respondents aging out of the eligibility
criteria (over the age of 18), we expect
to need to recruit a larger number of
cross-sectional respondents than in
previous waves. We estimate that
approximately 600 longitudinal youth
and 1,500 cross-sectional youth will
participate in each of the fourth and
fifth post-test surveys. With an
estimated burden of 45 minutes per
respondent, this adds 450 hours for
longitudinal respondents and 1,125
hours for cross-sectional respondents for
each of the fourth and fifth post-test
evaluation surveys.
A mail-based screener was one of the
methods used to identify eligible youth
for the pre-test survey. This method will
be used during the fourth post-test
survey to recruit new youth to ensure
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61005
that the sample composition is similar
across rounds of data collection. As was
done during the pre-test survey, parents
or guardians will be asked to provide
consent and their contact information
on this form. For the fourth post-test
survey, the 5-minute youth screener and
the 1-minute parental consent will be
completed by 9,869 households for a
total of 822 burden hours for youth and
an additional 164 hours for the parents
or guardians. This method will not be
used during the fifth post-test survey,
for which new participants will be
recruited only via social media.
We will continue to recruit new youth
through social media (e.g., Facebook,
Instagram) as a secondary strategy to
recruit youth 13 to 17. An online
version of the screener described above
will continue to be used to identify
eligible youth. The screener will take 5
minutes and will be completed by an
additional 4,000 youth during each of
the fourth and fifth post-test surveys, for
a total of 8,000 additional youth
respondents and 666 total additional
burden hours. The new total number of
participants for the youth online posttest screener will be 32,000 and the total
burden will be 2,666 hours. This
includes the originally-approved 24,000
participants and 2,000 burden hours.
As was done previously, eligible
youth aged 13 to 14 who complete the
online screener will be asked to provide
their parents’ or guardians’ contact
information to provide parental consent
for the main survey. The process of
parents and guardians providing
consent for eligible youth will take
approximately 1 minute. For the fourth
and fifth post-test surveys, we estimate
that an additional 700 adults will be
contacted to provide consent for eligible
youth for a total of 11 additional burden
hours. Added to the original 6,000
parents and 100 burden hours, the total
number of parental online screener and
consents will be 6,700 and the total
burden will be 111 hours.
With these additions, the estimated
number of respondents/responses for all
waves of data collection for the study is
107,743, and the total burden is
estimated at 15,135 hours—an increase
of 4,813 hours from the last approval.
FDA estimates the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
Number of responses per
respondent
Mail Screener and Consent
Process—Pre-test outcome survey.
Mail Screener and Consent
Process—Post-test outcome survey.
Mail Screener and Consent
Process—Pre-test outcome survey.
Online Screener and Consent Process—Pre-test
outcome survey.
Mail Screener and Consent
Process—Post-test outcome survey.
Online Screener and Consent Process—Post-test
outcome survey.
Pre-test outcome evaluation
survey.
13,816
1
13,816
0.0833
1,151
9,869
1
9,869
0.0833
822
13,816
1
13,816
0.0166
229
520
1
520
0.0166
9
9,869
1
9,869
0.0166
164
6,700
1
6,700
0.0166
111
2,194
1
2,194
0.5
1,097
First post-test evaluation
survey.
Second post-test evaluation
survey.
Third post-test evaluation
survey.
Fourth post-test evaluation
survey.
Fifth post-test evaluation
survey.
First post-test evaluation
survey.
Second post-test evaluation
survey.
Third post-test evaluation
survey.
Fourth post-test evaluation
survey.
Fifth post-test evaluation
survey.
Pre-test online screener .....
Post-test online screener ...
1,722
1
1,722
0.75
1,292
1,752
1
1,752
0.75
1,314
1,365
1
1,365
0.75
1,024
600
1
600
0.75
450
600
1
600
0.75
450
682
503
735
1,500
1,500
1
1
1
1
1
682
503
735
1,500
1,500
0.75
0.75
0.75
0.75
0.75
512
377
551
1,125
1,125
8,000
32,000
1
1
8,000
32,000
0.0833
0.0833
666
2,666
.............................................
107,743
........................
........................
........................
15,135
Type of respondent
Youth aged 12 to 17 in the
United States.
Adults 18 and older in the
United States.
Multicultural Youth aged 12
to 17 in select media
markets.
Longitudinal Cohort, age 13
to 18 years.
Cross-Sectional Refresher
Sample, age 13 to 17
years.
Multicultural youth aged 13
to 17 in the select media
markets recruiting through
social media and online
panels.
Total .............................
1 There
Activity
Average burden per response
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27712 Filed 12–22–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–E–2582]
BILLING CODE 4164–01–P
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Total annual
responses
Determination of Regulatory Review
Period for Purposes of Patent
Extension; STRIVERDI RESPIMAT
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SUMMARY:
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STRIVERDI RESPIMAT and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 26, 2018.
DATES:
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]]>Agencies
[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61003-61006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27712]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2294]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Evaluation of the
Food and Drug Administration's `Fresh Empire' Multicultural Youth
Tobacco Prevention Campaign
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 an extension of the time period for the
outcome evaluation of FDA's multicultural youth tobacco public
education campaign, the addition of two rounds of data collection with
the original youth surveyed for the outcome evaluation, and recruitment
of new youth to participate in those two additional surveys.
DATES: Submit either electronic or written comments on the collection
of information by February 26, 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 February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 26, 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.
[[Page 61004]]
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-2014-N-2294 for ``Evaluation of the Food and Drug Administration's
`Fresh Empire' Multicultural Youth Tobacco Prevention Campaign''
Received comments, those filed in a timely manner (see ADDRESSES), will
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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.
Evaluation of the Food and Drug Administration's `Fresh Empire'
Multicultural Youth Tobacco Prevention Campaign (OMB Control Number
0910-0788--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 (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 youth-targeted public education campaign (`Fresh
Empire') to help prevent tobacco use among multicultural youth and
thereby reduce the public health burden of tobacco. The campaign
features events, advertisements on television and radio and in print,
digital communications including social media, and other forms of
media.
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 multicultural public education
campaign will be used to document whether the intended audience is
aware of and understands campaign messages, and whether campaign
exposure influences specific cognitive outcomes related to tobacco use
that are targeted by the campaign.
[[Page 61005]]
FDA is in the process of evaluating the effectiveness of its
multicultural youth tobacco prevention campaign through an outcome
evaluation study that follows the multiple, discrete waves of media
advertising planned for the campaign. All information collected is
integral to that evaluation.
FDA's Fresh Empire youth tobacco public education campaign aims to
reduce tobacco use among youth who affiliate with a hip-hop peer crowd,
predominantly among African American, Hispanic, and Asian/Pacific
Islander youth. The outcome evaluation of the campaign consists of a
pre-test survey of youth aged 12 to 17 before campaign launch followed
by a series of post-test surveys beginning approximately 6 months after
the campaign launch. The post-test surveys are conducted among youth
who participated in one or more surveys (the embedded longitudinal
cohort) and new participants who are recruited to make up for
attrition. Eligible youth were initially 12- to 17-year-old youth who
are influenced by the hip-hop peer crowd. Youth in the embedded
longitudinal cohort may reach the age of 18 over the course of the
evaluation.
To date, the pre-test and two post-test surveys have been
conducted. A third post-test survey is currently underway. Information
has been collected about youth awareness of and exposure to campaign
events and advertisements and about tobacco-related knowledge,
attitudes, beliefs, intentions, and use. Information has also been
collected on demographic variables including age, sex, race/ethnicity,
grade level, and primary language.
All information is being collected through in-person and web-based
questionnaires. Youth respondents were recruited from two sources: (1)
A sample drawn from 30 U.S. media markets gathered using an address-
based postal mail sampling of U.S. households for the outcome
evaluation, and (2) targeted social media (e.g., Facebook).
This study is being conducted in support of the provisions of the
Tobacco Control Act that require FDA to protect the public health and
to educate the population about the risks and potential risks of
tobacco use. The information being collected is necessary to inform
FDA's efforts towards these goals and to measure the effectiveness and
public health impact of the campaign. Data from the outcome evaluation
are being used to estimate awareness of and exposure to the campaign
among youth in target markets where the campaign is active. Data are
also being used to examine statistical associations between exposure to
the campaign and subsequent changes in specific outcomes of interest,
which include knowledge, attitudes, and beliefs related to tobacco use.
FDA requests OMB approval to extend OMB approval of the evaluation
of FDA's multicultural youth tobacco public education campaign and to
add two additional waves of data collection with existing youth in the
study. To accommodate these two additional surveys, FDA requests
approval to increase the number of burden hours under the existing
control number. The fourth post-test survey will begin in July 2018.
The fifth post-test survey will begin in February 2019. As was done in
earlier post-test surveys, new youth will be recruited to participate
to make up for attrition.
A total of 2,100 youth will complete questionnaires for the fourth
post-test survey, and the same number will complete questionnaires for
the fifth post-test survey. These respondents will include existing
youth who have participated in one or more surveys previously
(``Longitudinal Cohort'') and new youth recruited via a mail-based
screener or social media ads (``Cross-Sectional Refresher Sample'').
Based on earlier response rates and longitudinal respondents aging out
of the eligibility criteria (over the age of 18), we expect to need to
recruit a larger number of cross-sectional respondents than in previous
waves. We estimate that approximately 600 longitudinal youth and 1,500
cross-sectional youth will participate in each of the fourth and fifth
post-test surveys. With an estimated burden of 45 minutes per
respondent, this adds 450 hours for longitudinal respondents and 1,125
hours for cross-sectional respondents for each of the fourth and fifth
post-test evaluation surveys.
A mail-based screener was one of the methods used to identify
eligible youth for the pre-test survey. This method will be used during
the fourth post-test survey to recruit new youth to ensure that the
sample composition is similar across rounds of data collection. As was
done during the pre-test survey, parents or guardians will be asked to
provide consent and their contact information on this form. For the
fourth post-test survey, the 5-minute youth screener and the 1-minute
parental consent will be completed by 9,869 households for a total of
822 burden hours for youth and an additional 164 hours for the parents
or guardians. This method will not be used during the fifth post-test
survey, for which new participants will be recruited only via social
media.
We will continue to recruit new youth through social media (e.g.,
Facebook, Instagram) as a secondary strategy to recruit youth 13 to 17.
An online version of the screener described above will continue to be
used to identify eligible youth. The screener will take 5 minutes and
will be completed by an additional 4,000 youth during each of the
fourth and fifth post-test surveys, for a total of 8,000 additional
youth respondents and 666 total additional burden hours. The new total
number of participants for the youth online post-test screener will be
32,000 and the total burden will be 2,666 hours. This includes the
originally-approved 24,000 participants and 2,000 burden hours.
As was done previously, eligible youth aged 13 to 14 who complete
the online screener will be asked to provide their parents' or
guardians' contact information to provide parental consent for the main
survey. The process of parents and guardians providing consent for
eligible youth will take approximately 1 minute. For the fourth and
fifth post-test surveys, we estimate that an additional 700 adults will
be contacted to provide consent for eligible youth for a total of 11
additional burden hours. Added to the original 6,000 parents and 100
burden hours, the total number of parental online screener and consents
will be 6,700 and the total burden will be 111 hours.
With these additions, the estimated number of respondents/responses
for all waves of data collection for the study is 107,743, and the
total burden is estimated at 15,135 hours--an increase of 4,813 hours
from the last approval.
FDA estimates the burden of this collection of information as
follows:
[[Page 61006]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Type of respondent Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth aged 12 to 17 in the United States.. Mail Screener and Consent 13,816 1 13,816 0.0833 1,151
Process--Pre-test outcome
survey.
Mail Screener and Consent 9,869 1 9,869 0.0833 822
Process--Post-test outcome
survey.
Adults 18 and older in the United States.. Mail Screener and Consent 13,816 1 13,816 0.0166 229
Process--Pre-test outcome
survey.
Online Screener and Consent 520 1 520 0.0166 9
Process--Pre-test outcome
survey.
Mail Screener and Consent 9,869 1 9,869 0.0166 164
Process--Post-test outcome
survey.
Online Screener and Consent 6,700 1 6,700 0.0166 111
Process--Post-test outcome
survey.
Multicultural Youth aged 12 to 17 in Pre-test outcome evaluation 2,194 1 2,194 0.5 1,097
select media markets. survey.
Longitudinal Cohort, age 13 to 18 years... First post-test evaluation 1,722 1 1,722 0.75 1,292
survey.
Second post-test evaluation 1,752 1 1,752 0.75 1,314
survey.
Third post-test evaluation 1,365 1 1,365 0.75 1,024
survey.
Fourth post-test evaluation 600 1 600 0.75 450
survey.
Fifth post-test evaluation 600 1 600 0.75 450
survey.
Cross-Sectional Refresher Sample, age 13 First post-test evaluation 682 1 682 0.75 512
to 17 years. survey. 503 1 503 0.75 377
Second post-test evaluation 735 1 735 0.75 551
survey. 1,500 1 1,500 0.75 1,125
Third post-test evaluation 1,500 1 1,500 0.75 1,125
survey.
Fourth post-test evaluation
survey.
Fifth post-test evaluation
survey.
Multicultural youth aged 13 to 17 in the Pre-test online screener.... 8,000 1 8,000 0.0833 666
select media markets recruiting through Post-test online screener... 32,000 1 32,000 0.0833 2,666
social media and online panels.
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Total................................. ............................ 107,743 .............. .............. .............. 15,135
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27712 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P
