Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Study of Assessing Physiological, Neural and Self-Reported Response to Tobacco Education Messages, 24994-24996 [2023-08684]
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Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Mail, telephone, web-based survey ................
1 There
Dated: April 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08640 Filed 4–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2022–N–2657]
85,000
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: Submit written comments
(including recommendations) on the
collection of information by May 25,
2023.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is ‘‘Food
and Drug Administration’s Study of
Assessing Physiological, Neural and
Self-Reported Response to Tobacco
ADDRESSES:
VerDate Sep<11>2014
16:47 Apr 24, 2023
Jkt 259001
Education Messages.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
OMB Control Number 0910–NEW
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration’s Study of Assessing
Physiological, Neural and SelfReported Response to Tobacco
Education Messages
lotter on DSK11XQN23PROD with NOTICES1
1
Food and Drug Administration’s Study
of Assessing Physiological, Neural and
Self-Reported Response to Tobacco
Education Messages
Food and Drug Administration
ACTION:
85,000
Total annual
responses
Average burden
per response
.42 (25 minutes) .................
Total hours
35,700
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last OMB approval of this
information collection request, FDA
submitted three requests to increase the
total burden hours. Therefore, this
request for extension of OMB approval
adjusts the number of respondents by an
increase of 30,000 and the total burden
hours by an increase of 21,950.
AGENCY:
Number of
responses per
respondent
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act granted FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products; to inform the public on
health-related issues; and to protect
public health by reducing tobacco use
and by preventing death and disease
caused by tobacco use.
FDA’s Center for Tobacco Products
(CTP) was created to carry out the
authorities granted under the Tobacco
Control Act, to educate the public about
the dangers of tobacco use and serve as
a public health resource for tobacco and
health information. Through CTP, FDA
researches, develops, and distributes
information about tobacco and health to
the public, professionals, various
branches of government, and other
interested groups nationwide using a
wide array of formats and media
channels. FDA’s ‘‘The Real Cost’’
campaign (https://www.fda.gov/tobaccoproducts/public-health-educationcampaigns/real-cost-campaign) uses
evidence-based paid media advertising
to highlight the negative health
consequences of tobacco use. To
develop the appropriate messaging to
inform the public, it is important for
FDA to conduct research to assess youth
and young adults’ perceptions of
tobacco use prevention messaging.
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
The study of ‘‘Assessing
Physiological, Neural and Self-Reported
Response to Tobacco Education
Messages’’ is voluntary research.
Information obtained through this study
will primarily be used to assess the
performance of ads developed to reduce
tobacco initiation and use among at-risk
youth and young adults as part of CTP’s
‘‘The Real Cost’’ campaign.
Traditionally, message testing research
employs self-reported measures of
perceived effectiveness (e.g., an
individual’s perception that the ad
would make one less likely to use
tobacco), but research indicates that
while these self-reported measures are
useful, they may be imperfect proxies
for real world knowledge, attitude, and
behavior change. This imprecision
could lead message developers to select
less than optimal messages or costineffective strategies for widespread
dissemination.
Physiological and neural responses to
tobacco education messages offer an
innovative and useful supplement to
traditional self-report measures.
Indicators such as heart rate variability,
galvanic skin response, and facial
electromyography can assess arousal
and affective response to messages,
while tools such as eye tracking and
neuroimaging can measure attention
and levels of activation in key areas in
the brain associated with message
processing and message acceptance.
Research indicates that these techniques
can be more effective than self-report
measures at predicting ‘‘real world’’
tobacco education message
effectiveness.
There is a need for research that
implements these techniques to identify
the most effective tobacco prevention
and education message strategies.
Additionally, there is a need to
triangulate data collected through
physiological and neuroimaging-based
approaches with self-reported measures
to better understand how self-reported
measures can be implemented in order
to accurately predict knowledge,
attitude, and behavior change.
This study will recruit participants
from the Baltimore, Maryland area to
participate in an in-person study visit at
Johns Hopkins University Bloomberg
School of Public Health. Inclusion and
E:\FR\FM\25APN1.SGM
25APN1
Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices
exclusion criteria are based on the target
populations for ‘‘The Real Cost’’
campaign. Specifically, the study will
collect data from two groups: 50 youth
(aged 13–17) and 50 young adults (aged
18–24 years old). Participants will be
stratified by electronic nicotine delivery
systems and cigarette use, so that
approximately half of each sample will
be: (1) at risk for initiating a tobacco
product (i.e., think they might try one in
the near future or would try one if a
friend offered it to them) or (2) tobacco
experimenter (have had at least 1 but
less than 100 cigarettes in their lifetime;
have had at least 1 puff of an ecigarette). Individuals who respond that
they have never used tobacco products
and respond ‘‘definitely not’’ to all
questions assessing openness to tobacco
use will be excluded from participation.
Additionally, those who have
established tobacco use patterns will be
excluded from participation. Both
groups are outside the target
demographic for ‘‘The Real Cost’’
campaign.
The study will use community-based
recruiting, using methods such as flyers
posted at locations frequented by young
adults, teenagers, and their parents (e.g.,
local Baltimore City colleges, markets,
and other relevant venues), social
media, and word-of-mouth. Flyers will
be posted with permission and advertise
the study as assessing perceptions of
tobacco education messages using
monitors placed on the head, face, and
fingers; special glasses; and a survey.
Participants will be directed to complete
an online screening survey before
scheduling their study visit.
For youth participants, eligible
participants will provide contact
information for their parent/guardian.
The study team will then contact the
parent and receive parental permission
and schedule a study visit. At the study
visit, study personnel will confirm that
13–15-year-olds are accompanied by
someone 18 or older and then the youth
will provide assent. For young adult
participants, after completing the
screener, eligible participants will
provide their contact information. The
study team will then contact the
participant and schedule a study visit.
At the study visit, young adult
participants will provide informed
consent prior to beginning study
participation.
After the consenting/assenting
process, participants will complete one
study visit (90 minutes long) in which
they will view four FDA tobacco
education and prevention ads. First,
participants will complete a survey and
be fitted with neuroimaging and
psychophysiological equipment.
Second, participants will be fitted for a
functional near-infrared spectroscopy
(fNIRS) headband (the headband can be
adjusted based on head circumference)
and then have the fNIRS headband and
24995
electrodes for physiological data
collection, and eye-tracking glasses
placed on them. They will then
complete a series of computer tasks to
ensure placement of the fNIRS
headband and fill out part one of the
survey on demographic characteristics,
tobacco use behaviors, and social
influence related to tobacco use. Next,
they will view tobacco education
messages, and complete part two of the
survey providing self-reported response
data (e.g., how much they liked the ad)
after each message. Participants will
conclude the survey by completing the
third part of the survey assessing
psychosocial variables. Participants will
receive a small incentive as a token of
appreciation in exchange for their
survey participation. Additionally, for
youth (ages 13–15) participants, the
adult who accompanies the youth will
receive a token of appreciation in
exchange for costs of accompanying the
youth to the study site (e.g., parking,
gas, and potential loss of income/
childcare needed for youth to
participate).
In the Federal Register of November
22, 2022 (87 FR 71335), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was received
that 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
Participant subgroup
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours 1
Number to take the eligibility screener
Youth (aged 13–17) ........................................
Young adults (aged 18–24) ............................
150
150
1
1
150
150
0.083 (5 minutes) ...............
0.083 (5 minutes) ...............
13
13
Total .........................................................
........................
........................
........................
.............................................
26
Number to obtain parental permission process (for parents of youth only) and schedule site visit
Parents of youth participants ..........................
Young adults (aged 18–24) ............................
75
50
1
1
75
50
0.167 (10 minutes) .............
0.083 (5 minutes) ...............
13
4
Total .........................................................
........................
........................
........................
.............................................
17
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Number to complete consent (5 min) and main study (85 min)
Youth (aged 13–17) ........................................
Young adults (aged 18–24) ............................
50
50
1
1
50
50
1.5 ......................................
1.5 ......................................
75
75
Total .........................................................
........................
........................
........................
.............................................
150
Total ..................................................
........................
........................
........................
.............................................
193
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with research that is
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16:47 Apr 24, 2023
Jkt 259001
similar to this proposed study. Applying
assumptions from previous experience
PO 00000
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Fmt 4703
Sfmt 4703
in conducting similar studies,
approximately 150 youth and 150 young
E:\FR\FM\25APN1.SGM
25APN1
24996
Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices
adults would take the eligibility
screener, which is estimated to take 5
minutes to read and respond. An
estimated 75 parents of youth
participants will provide parental
permission and schedule a site visit (10
minutes total), and an estimated 50
young adults will schedule a site visit
(5 minutes). Finally, approximately 50
youth and 50 young adults will
complete an in-person study visit that
consists of the consent/assent (5
minutes) and complete the main study
(85 minutes) to yield the desired sample
size of 100 total. The total estimated
burden for the data collection is 193
hours. Table 1 details these estimates.
Dated: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08684 Filed 4–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1357]
Authorization of Emergency Use of a
Medical Device During COVID–19;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the issuance of an
Emergency Use Authorization (EUA)
(the Authorization) for a medical device
related to the Coronavirus Disease 2019
(COVID–19) public health emergency.
FDA has issued the Authorization
indicated in this document under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act). This Authorization
contains, among other things,
conditions on the emergency use of the
authorized product. The Authorization
follows the February 4, 2020,
determination by the Secretary of Health
and Human Services (HHS), as amended
on March 15, 2023, that there is a public
health emergency, or a significant
potential for a public health emergency,
that affects, or has a significant potential
to affect, national security or the health
and security of U.S. citizens living
abroad and that involves the virus that
causes COVID–19, and the subsequent
declarations on February 4, 2020, March
2, 2020, and March 24, 2020, that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection and/or
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:47 Apr 24, 2023
Jkt 259001
diagnosis of the virus that causes
COVID–19, personal respiratory
protective devices, and medical devices,
including alternative products used as
medical devices, respectively, subject to
the terms of any authorization issued
under the FD&C Act. The Authorization,
which includes an explanation of the
reasons for issuance, is specified in this
document, and can be accessed on
FDA’s website from the links indicated.
DATES: The Authorization is effective on
the date of issuance.
ADDRESSES: Submit written requests for
single copies of an EUA to the Office of
Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a Fax number to which the
Authorization may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT: Kim
Sapsford-Medintz, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216,
Silver Spring, MD 20993–0002, 301–
796–0311 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen the public health protections
against biological, chemical,
radiological, or nuclear agent or agents.
Among other things, section 564 of the
FD&C Act allows FDA to authorize the
use of an unapproved medical product
or an unapproved use of an approved
medical product in certain situations.
With this EUA authority, FDA can help
ensure that medical countermeasures
may be used in emergencies to diagnose,
treat, or prevent serious or lifethreatening diseases or conditions
caused by a biological, chemical,
radiological, or nuclear agent or agents
when there are no adequate, approved,
and available alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) a
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50 of the
U.S. Code, of attack with (A) a
biological, chemical, radiological, or
nuclear agent or agents; or (B) an agent
or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces; 1 (3) a
determination by the Secretary of HHS
that there is a public health emergency,
or a significant potential for a public
health emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad, and that
involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Under section
564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available
on the internet website of FDA. Section
564 of the FD&C Act permits FDA to
authorize the introduction into
interstate commerce of a drug, device, or
biological product intended for use
when the Secretary of HHS has declared
that circumstances exist justifying the
authorization of emergency use.
Products appropriate for emergency use
may include products and uses that are
not approved, cleared, or licensed under
section 505, 510(k), 512, or 515 of the
FD&C Act (21 U.S.C. 355, 360(k), 360b,
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24994-24996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2657]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Drug
Administration's Study of Assessing Physiological, Neural and Self-
Reported Response to Tobacco Education Messages
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by May 25, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Food and Drug Administration's Study of
Assessing Physiological, Neural and Self-Reported Response to Tobacco
Education Messages.'' Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Food and Drug Administration's Study of Assessing Physiological, Neural
and Self-Reported Response to Tobacco Education Messages
OMB Control Number 0910-NEW
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act granted FDA authority to regulate
the manufacture, marketing, and distribution of tobacco products; to
inform the public on health-related issues; and to protect public
health by reducing tobacco use and by preventing death and disease
caused by tobacco use.
FDA's Center for Tobacco Products (CTP) was created to carry out
the authorities granted under the Tobacco Control Act, to educate the
public about the dangers of tobacco use and serve as a public health
resource for tobacco and health information. Through CTP, FDA
researches, develops, and distributes information about tobacco and
health to the public, professionals, various branches of government,
and other interested groups nationwide using a wide array of formats
and media channels. FDA's ``The Real Cost'' campaign (https://www.fda.gov/tobacco-products/public-health-education-campaigns/real-cost-campaign) uses evidence-based paid media advertising to highlight
the negative health consequences of tobacco use. To develop the
appropriate messaging to inform the public, it is important for FDA to
conduct research to assess youth and young adults' perceptions of
tobacco use prevention messaging.
The study of ``Assessing Physiological, Neural and Self-Reported
Response to Tobacco Education Messages'' is voluntary research.
Information obtained through this study will primarily be used to
assess the performance of ads developed to reduce tobacco initiation
and use among at-risk youth and young adults as part of CTP's ``The
Real Cost'' campaign. Traditionally, message testing research employs
self-reported measures of perceived effectiveness (e.g., an
individual's perception that the ad would make one less likely to use
tobacco), but research indicates that while these self-reported
measures are useful, they may be imperfect proxies for real world
knowledge, attitude, and behavior change. This imprecision could lead
message developers to select less than optimal messages or cost-
ineffective strategies for widespread dissemination.
Physiological and neural responses to tobacco education messages
offer an innovative and useful supplement to traditional self-report
measures. Indicators such as heart rate variability, galvanic skin
response, and facial electromyography can assess arousal and affective
response to messages, while tools such as eye tracking and neuroimaging
can measure attention and levels of activation in key areas in the
brain associated with message processing and message acceptance.
Research indicates that these techniques can be more effective than
self-report measures at predicting ``real world'' tobacco education
message effectiveness.
There is a need for research that implements these techniques to
identify the most effective tobacco prevention and education message
strategies. Additionally, there is a need to triangulate data collected
through physiological and neuroimaging-based approaches with self-
reported measures to better understand how self-reported measures can
be implemented in order to accurately predict knowledge, attitude, and
behavior change.
This study will recruit participants from the Baltimore, Maryland
area to participate in an in-person study visit at Johns Hopkins
University Bloomberg School of Public Health. Inclusion and
[[Page 24995]]
exclusion criteria are based on the target populations for ``The Real
Cost'' campaign. Specifically, the study will collect data from two
groups: 50 youth (aged 13-17) and 50 young adults (aged 18-24 years
old). Participants will be stratified by electronic nicotine delivery
systems and cigarette use, so that approximately half of each sample
will be: (1) at risk for initiating a tobacco product (i.e., think they
might try one in the near future or would try one if a friend offered
it to them) or (2) tobacco experimenter (have had at least 1 but less
than 100 cigarettes in their lifetime; have had at least 1 puff of an
e-cigarette). Individuals who respond that they have never used tobacco
products and respond ``definitely not'' to all questions assessing
openness to tobacco use will be excluded from participation.
Additionally, those who have established tobacco use patterns will be
excluded from participation. Both groups are outside the target
demographic for ``The Real Cost'' campaign.
The study will use community-based recruiting, using methods such
as flyers posted at locations frequented by young adults, teenagers,
and their parents (e.g., local Baltimore City colleges, markets, and
other relevant venues), social media, and word-of-mouth. Flyers will be
posted with permission and advertise the study as assessing perceptions
of tobacco education messages using monitors placed on the head, face,
and fingers; special glasses; and a survey. Participants will be
directed to complete an online screening survey before scheduling their
study visit.
For youth participants, eligible participants will provide contact
information for their parent/guardian. The study team will then contact
the parent and receive parental permission and schedule a study visit.
At the study visit, study personnel will confirm that 13-15-year-olds
are accompanied by someone 18 or older and then the youth will provide
assent. For young adult participants, after completing the screener,
eligible participants will provide their contact information. The study
team will then contact the participant and schedule a study visit. At
the study visit, young adult participants will provide informed consent
prior to beginning study participation.
After the consenting/assenting process, participants will complete
one study visit (90 minutes long) in which they will view four FDA
tobacco education and prevention ads. First, participants will complete
a survey and be fitted with neuroimaging and psychophysiological
equipment. Second, participants will be fitted for a functional near-
infrared spectroscopy (fNIRS) headband (the headband can be adjusted
based on head circumference) and then have the fNIRS headband and
electrodes for physiological data collection, and eye-tracking glasses
placed on them. They will then complete a series of computer tasks to
ensure placement of the fNIRS headband and fill out part one of the
survey on demographic characteristics, tobacco use behaviors, and
social influence related to tobacco use. Next, they will view tobacco
education messages, and complete part two of the survey providing self-
reported response data (e.g., how much they liked the ad) after each
message. Participants will conclude the survey by completing the third
part of the survey assessing psychosocial variables. Participants will
receive a small incentive as a token of appreciation in exchange for
their survey participation. Additionally, for youth (ages 13-15)
participants, the adult who accompanies the youth will receive a token
of appreciation in exchange for costs of accompanying the youth to the
study site (e.g., parking, gas, and potential loss of income/childcare
needed for youth to participate).
In the Federal Register of November 22, 2022 (87 FR 71335), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received that was not PRA
related.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Participant subgroup Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to take the eligibility screener
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth (aged 13-17)....................... 150 1 150 0.083 (5 minutes)............................ 13
Young adults (aged 18-24)................ 150 1 150 0.083 (5 minutes)............................ 13
--------------------------------------------------------------------------------------------------------------
Total................................ .............. .............. .............. ............................................. 26
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to obtain parental permission process (for parents of youth only) and schedule site visit
--------------------------------------------------------------------------------------------------------------------------------------------------------
Parents of youth participants............ 75 1 75 0.167 (10 minutes)........................... 13
Young adults (aged 18-24)................ 50 1 50 0.083 (5 minutes)............................ 4
--------------------------------------------------------------------------------------------------------------
Total................................ .............. .............. .............. ............................................. 17
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to complete consent (5 min) and main study (85 min)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth (aged 13-17)....................... 50 1 50 1.5.......................................... 75
Young adults (aged 18-24)................ 50 1 50 1.5.......................................... 75
--------------------------------------------------------------------------------------------------------------
Total................................ .............. .............. .............. ............................................. 150
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Total............................ .............. .............. .............. ............................................. 193
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's burden estimate is based on prior experience with research
that is similar to this proposed study. Applying assumptions from
previous experience in conducting similar studies, approximately 150
youth and 150 young
[[Page 24996]]
adults would take the eligibility screener, which is estimated to take
5 minutes to read and respond. An estimated 75 parents of youth
participants will provide parental permission and schedule a site visit
(10 minutes total), and an estimated 50 young adults will schedule a
site visit (5 minutes). Finally, approximately 50 youth and 50 young
adults will complete an in-person study visit that consists of the
consent/assent (5 minutes) and complete the main study (85 minutes) to
yield the desired sample size of 100 total. The total estimated burden
for the data collection is 193 hours. Table 1 details these estimates.
Dated: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08684 Filed 4-24-23; 8:45 am]
BILLING CODE 4164-01-P
