Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Fresh Empire Campaign on Tobacco, 16863-16865 [2018-07971]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
sooner as determined by CMS. DNV
GL—Healthcare (DNV GL) current term
of approval for their hospital
accreditation program expires
September 26, 2018.
II. Provisions of the Proposed Notice
A. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.5 require that our
findings concerning review and
approval of a national accrediting
organization’s requirements consider,
among other factors, the applying
accrediting organization’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide us with the necessary
data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of DNV GL’s
request for continued approval of its
hospital accreditation program. This
notice also solicits public comment on
whether DNV GL’s requirements meet or
exceed the Medicare conditions of
participation (CoPs) for hospitals.
daltland on DSKBBV9HB2PROD with NOTICES
B. Evaluation of Deeming Authority
Request
DNV GL submitted all the necessary
materials to enable us to make a
determination concerning its request for
continued approval of its hospital
accreditation program. This application
was determined to be complete on
February 28, 2018. Under section
1865(a)(2) of the Act and our regulations
at § 488.5 (Application and reapplication procedures for national
accrediting organizations), our review
and evaluation of DNV GL will be
conducted in accordance with, but not
necessarily limited to, the following
factors:
• The equivalency of DNV GL’s
standards for hospitals as compared
with CMS’ hospital CoPs.
• DNV GL’s survey process to
determine the following:
++ The composition of the survey
team, surveyor qualifications, and the
VerDate Sep<11>2014
19:20 Apr 16, 2018
Jkt 244001
ability of the organization to provide
continuing surveyor training.
++ The comparability of DNV GL’s
processes to those of state agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities.
++ DNV GL’s processes and
procedures for monitoring a hospital
found out of compliance with the DNV
GL’s program requirements. These
monitoring procedures are used only
when the DNV GL identifies
noncompliance. If noncompliance is
identified through validation reviews or
complaint surveys, the state survey
agency monitors corrections as specified
at § 488.9(c).
++ DNV GL’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ DNV GL’s capacity to provide CMS
with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of DNV GL’s staff
and other resources, and its financial
viability.
++ DNV GL’s capacity to adequately
fund required surveys.
++ DNV GL’s policies with respect to
whether surveys are announced or
unannounced, to assure that surveys are
unannounced.
++ DNV GL’s agreement to provide
CMS with a copy of the most current
accreditation survey together with any
other information related to the survey
as we may require (including corrective
action plans).
C. Notice Upon Completion of
Evaluation
III. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
Frm 00041
Fmt 4703
Sfmt 4703
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Dated: April 9, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–07982 Filed 4–16–18; 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
Fresh Empire Campaign on Tobacco
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
(the PRA).
DATES: Fax written comments on the
collection of information by May 17,
2018.
SUMMARY:
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 0910–0788. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Upon completion of our evaluation,
including evaluation of public
comments received as a result of this
notice, we will publish a final notice in
the Federal Register announcing the
result of our evaluation.
PO 00000
16863
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
E:\FR\FM\17APN1.SGM
17APN1
16864
Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
collection of information to OMB for
review and clearance.
daltland on DSKBBV9HB2PROD with NOTICES
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 (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.
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
VerDate Sep<11>2014
19:20 Apr 16, 2018
Jkt 244001
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 years old and
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 three posttest surveys have been conducted.
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 voluntarily
provided and 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, Instagram).
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.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
A total of 2,100 youth will voluntarily
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
voluntarily 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 aged 12 to
17 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 5minute 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 aged 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 to complete and will be taken
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 voluntary 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
E:\FR\FM\17APN1.SGM
17APN1
Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
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 screeners and
consents will be 6,700 and the total
burden will be 111 hours.
With these additions, the estimated
number of voluntary respondents/
responses for all waves of data
collection for the study is 107,743, and
the total burden is estimated at 15,135
16865
hours—an estimated increase of 4,813
hours from the last approval.
In the Federal Register of December
26, 2017 (82 FR 61003), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was
received; however, this comment was
not PRA related.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of respondent/activity
Youth Mail screener-outcome survey ......................
Cross-Sectional Youth Refresher Sample, Post-test
and assent/consent process-outcome surveys 1–
5.
Youth Pre-test and assent/consent process-outcome survey.
Longitudinal Youth Cohort, Post-test and assent/
consent process-outcome surveys 1–5.
Youth Online screener-outcome survey ..................
Adult parental permission process-outcome survey
Total ..................................................................
1 There
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Total hours
1
1
23,685
4,920
0.0833 (5 minutes) ....
0.75 (45 minutes) ......
1,973
3,690
2,194
1
2,194
0.50 (30 minutes) ......
1,097
6,039
1
6,039
0.75 (45 minutes) ......
4,530
40,000
30,905
1
1
40,000
30,905
0.0833 (5 minutes) ....
0.0166 (1 minute) ......
3,332
513
107,743
........................
........................
....................................
15,135
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2014–N–0913]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; 513(g) Request for
Information
Food and Drug Administration,
HHS.
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 May 17,
2018.
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
Average burden per
response
23,685
4,920
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 0910–0705. Also
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2018–07971 Filed 4–16–18; 8:45 am]
ACTION:
Total annual
responses
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
ADDRESSES:
VerDate Sep<11>2014
19:20 Apr 16, 2018
Jkt 244001
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.
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:
513(g) Request for Information
OMB Control Number 0910–0705—
Extension
This information collection supports
Agency regulations and accompanying
guidance. Section 513(g) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c(g)) provides
a means for obtaining the Agency’s
views about the classification and
regulatory requirements that may be
applicable to a particular device.
Section 513(g) provides that, within 60
days of the receipt of a written request
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
of any person for information respecting
the class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act, the
Secretary of Health and Human Services
shall provide such person a written
statement of the classification (if any) of
such device and the requirements of the
FD&C Act applicable to the device.
Regulations governing medical device
classification procedures are codified
under 21 CFR part 860.
The guidance document entitled
‘‘FDA and Industry Procedures for
Section 513(g) Requests for Information
Under the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry
and Food and Drug Administration
Staff’’ establishes procedures for
submitting, reviewing, and responding
to requests for information respecting
the class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act that are
submitted in accordance with section
513(g) of the FD&C Act. FDA does not
review data related to substantial
equivalence or safety and effectiveness
in a 513(g) request for information.
FDA’s responses to 513(g) requests for
information are not device classification
decisions and do not constitute FDA
clearance or approval for marketing.
Classification decisions and clearance or
approval for marketing require
submissions under different sections of
the FD&C Act.
E:\FR\FM\17APN1.SGM
17APN1
]]>Agencies
[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16863-16865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07971]
-----------------------------------------------------------------------
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
Fresh Empire Campaign on Tobacco
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 (the PRA).
DATES: Fax written comments on the collection of information by May 17,
2018.
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 0910-0788.
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
[[Page 16864]]
collection of information to OMB for review and clearance.
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 (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.
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 years old and
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 three post-test surveys have been
conducted. 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 voluntarily provided and 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, Instagram).
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 voluntarily 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 voluntarily 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 aged 12 to 17 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 aged 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
to complete and will be taken 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 voluntary 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
[[Page 16865]]
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 screeners and
consents will be 6,700 and the total burden will be 111 hours.
With these additions, the estimated number of voluntary
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
estimated increase of 4,813 hours from the last approval.
In the Federal Register of December 26, 2017 (82 FR 61003), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received; however, this
comment was not PRA related.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent/activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth Mail screener-outcome survey.......... 23,685 1 23,685 0.0833 (5 minutes)........................ 1,973
Cross-Sectional Youth Refresher Sample, Post- 4,920 1 4,920 0.75 (45 minutes)......................... 3,690
test and assent/consent process-outcome
surveys 1-5.
Youth Pre-test and assent/consent process- 2,194 1 2,194 0.50 (30 minutes)......................... 1,097
outcome survey.
Longitudinal Youth Cohort, Post-test and 6,039 1 6,039 0.75 (45 minutes)......................... 4,530
assent/consent process-outcome surveys 1-5.
Youth Online screener-outcome survey........ 40,000 1 40,000 0.0833 (5 minutes)........................ 3,332
Adult parental permission process-outcome 30,905 1 30,905 0.0166 (1 minute)......................... 513
survey.
------------------------------------------------ ---------------
Total................................... 107,743 .............. .............. .......................................... 15,135
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07971 Filed 4-16-18; 8:45 am]
BILLING CODE 4164-01-P`
