Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications, 60999-61001 [2020-21452]
Download as PDF
<![CDATA[
60999
Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUPPLEMENTARY INFORMATION:
Description: The NSECE COVID–19
Follow-up will collect information from
center-based ECE providers of care to
children birth through age 5 (not yet in
kindergarten), home-based ECE
providers that serve children under age
13, as well as the ECE workforce
providing these services. The proposed
collection will consist of the following
three coordinated nationally
representative surveys:
1. A two-wave survey of individuals
who provided paid care for children
under the age of 13 in a residential
setting, as of 2019, and who participated
in the 2019 NSECE (Home-based
Provider Interview);
2. a two-wave survey of providers of
care to children ages 0 through 5 years
of age (not yet in kindergarten) in a nonresidential setting (Center-based
Provider Interview), as of 2019, and who
participated in the 2019 NSECE; and
3. a two-wave survey conducted with
individuals employed in center-based
child care programs working directly
with children in classrooms (Centerbased Classroom Staff [Workforce]
Interview), as of 2019, and who
participated in the 2019 NSECE.
The NSECE COVID–19 Follow-up will
provide urgently needed information
about the supply of child care and early
education available to families across all
income levels, including providers
serving low-income families of various
racial, ethnic, language, and cultural
backgrounds, in diverse geographic
areas. The study will also dramatically
extend the available resources for
understanding the national impact of
the COVID–19 pandemic on the
country’s ECE supply and workforce,
including geographic variation therein.
Accurate data on the availability and
characteristics of ECE programs are
essential to assess the current and
changing landscape of child care and
early education programs and
understand the ability of the nation’s
supply and workforce to meet the needs
of parents of young children in the postpandemic economy, and will provide
insights to advance policy and
initiatives in the ECE field.
Respondents: Home-based providers,
as of 2019, serving children under 13
years of age (listed and unlisted paid)—
regardless of their status serving
children in 2020–2021; center-based
child care providers, as of 2019, serving
children ages 0 through 5 years of age
(not yet in kindergarten)—regardless of
their status serving children in 2020–
2021; and classroom-assigned
instructional staff members working
with children ages 0 through 5 years of
age (not yet in kindergarten) in centerbased child care providers, as of 2019,
regardless of their employment status in
2020–2021.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Home-based Provider Interview, Waves 1 and 2 ............................................
Center-based Provider Interview, Waves 1 and 2 ..........................................
Center-based Classroom Staff (Workforce) Interview, Waves 1 and 2 ..........
Estimated Total Annual Burden
Hours: 6,316.
Authority: Child Care and Development
Block Grant Act (42 U.S.C. 9858 et. seq.).
John M. Sweet Jr,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–21509 Filed 9–28–20; 8:45 am]
BILLING CODE 4184–23–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0987]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative Data
on Tobacco Products and
Communications
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
VerDate Sep<11>2014
18:14 Sep 28, 2020
Jkt 250001
3,375
5,850
3,533
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 generic clearance
for the collection of qualitative data on
tobacco products and communications.
DATES: Submit either electronic or
written comments on the collection of
information by November 30, 2020.
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 November 30,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 30, 2020.
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.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1.5
1.5
1.5
Average
burden
hours per
response
.33
.33
.33
Annual
burden
hours
1,671
2,896
1,749
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’’).
E:\FR\FM\29SEN1.SGM
29SEN1
61000
Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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–0987 for ‘‘Generic Clearance for
the Collection of Qualitative Data on
Tobacco Products and
Communications.’’ 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, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
VerDate Sep<11>2014
18:14 Sep 28, 2020
Jkt 250001
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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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.
Generic Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications
OMB Control Number 0910–0796—
Extension
Under section 1003(d)(2)(D) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(d)(2)(D)), FDA is
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
authorized to conduct educational and
public information programs.
In conducting studies relating to the
regulation and communications related
to tobacco products, FDA will need to
employ formative qualitative research
including focus groups, usability
testing, and/or in-depth interviews
(IDIs) to assess knowledge and
perceptions about tobacco-related topics
with specific target audiences. The
information collected will serve three
major purposes. First, formative
research will provide critical knowledge
about target audiences. FDA must first
understand people’s knowledge and
perceptions about tobacco related topics
prior to developing survey/research
questions as well as stimuli for
experimental studies. Second, by
collecting communications usability
information, FDA will be able to serve
and respond to the ever-changing
demands of consumers of tobacco
products. Additionally, we will be able
to determine the best way to present
messages. Third, initial testing will
allow FDA to assess consumer
understanding of survey/research
questions and study stimuli. Focus
groups and/or IDIs with a sample of the
target audience will allow FDA to refine
the survey/research questions and study
stimuli while they are still in the
developmental stage. FDA will collect,
and interpret information gathered
through this generic clearance in order
to: (1) Better understand characteristics
of the target audience—its perceptions,
knowledge, attitudes, beliefs, and
behaviors—and use these in the
development of appropriate survey/
research questions, study stimuli, or
communications; (2) more efficiently
and effectively design survey/research
questions and study stimuli; and (3)
more efficiently and effectively design
experimental studies.
FDA is requesting approval of an
extension of this generic clearance for
collecting information using qualitative
methods (i.e., individual interviews,
small group discussions, and focus
groups) for studies involving all tobacco
products regulated by FDA. This
information will be used as a first step
to explore concepts of interest and assist
in the development of quantitative
study proposals, complementing other
important research efforts in the
Agency. This information may also be
used to help identify and develop
communication messages, which may
be used in education campaigns. Focus
groups play an important role in
gathering information because they
allow for an in-depth understanding of
individuals’ attitudes, beliefs,
motivations, and feelings. Focus group
E:\FR\FM\29SEN1.SGM
29SEN1
Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices
research serves the narrowly defined
need for direct and informal public
opinion on a specific topic.
61001
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
response
Total annual
responses
Total hours
In-Person Individual In-depth Interviews.
In-depth Interview (IDI) Screener .....
Focus Group Screener .....................
Focus Group Interviews ....................
1,092
1
1,092
1 .......................................................
1,092
1,800
19,385
5,897
1
1
1
1,800
19,385
5,897
0.083 (5 minutes) .............................
0.25 (15 minutes) .............................
1.5 ....................................................
150
4,846
8,846
Total ...........................................
........................
........................
........................
...........................................................
14,934
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be
included in each new pretest may vary,
depending on the nature of the material
or message being tested and the target
audience. Table 1 provides examples of
the types of studies that may be
administered and estimated burden
levels during the 3-year period. Time to
read, view, or listen to the message
being tested is built into the ‘‘Hours per
Response’’ figures. Our estimated
burden for the information collection
reflects an overall increase of 5,641
hours and a corresponding increase of
16,585 responses. We attribute this
adjustment to the number of study
responses used during the current
approval and now estimated for the next
3 years.
Dated: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–21452 Filed 9–28–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4467]
Breast Implants—Certain Labeling
Recommendations To Improve Patient
Communication; Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Breast Implants—
Certain Labeling Recommendations to
Improve Patient Communication.’’ This
guidance contains recommendations
concerning the content and format for
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of interview
VerDate Sep<11>2014
18:14 Sep 28, 2020
Jkt 250001
certain labeling information for saline
and silicone gel-filled breast implants.
FDA is issuing this guidance to help
ensure that a patient receives and
understands the benefits and risks of
breast implants. These labeling
recommendations are intended to
enhance, but not replace, the physicianpatient discussion of the benefits and
risks of breast implants that uniquely
pertain to individual patients.
DATES: The announcement of the
guidance is published in the Federal
Register on September 29, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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’’).
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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–
2019–D–4467 for ‘‘Breast Implants—
Certain Labeling Recommendations to
Improve Patient Communication.’’
Received comments 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, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 60999-61001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21452]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0987]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for the Collection of Qualitative
Data on Tobacco Products and Communications
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 generic clearance for the collection of
qualitative data on tobacco products and communications.
DATES: Submit either electronic or written comments on the collection
of information by November 30, 2020.
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 November 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 30, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
[[Page 61000]]
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-0987 for ``Generic Clearance for the Collection of
Qualitative Data on Tobacco Products and Communications.'' 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, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Generic Clearance for the Collection of Qualitative Data on Tobacco
Products and Communications
OMB Control Number 0910-0796--Extension
Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational
and public information programs.
In conducting studies relating to the regulation and communications
related to tobacco products, FDA will need to employ formative
qualitative research including focus groups, usability testing, and/or
in-depth interviews (IDIs) to assess knowledge and perceptions about
tobacco-related topics with specific target audiences. The information
collected will serve three major purposes. First, formative research
will provide critical knowledge about target audiences. FDA must first
understand people's knowledge and perceptions about tobacco related
topics prior to developing survey/research questions as well as stimuli
for experimental studies. Second, by collecting communications
usability information, FDA will be able to serve and respond to the
ever-changing demands of consumers of tobacco products. Additionally,
we will be able to determine the best way to present messages. Third,
initial testing will allow FDA to assess consumer understanding of
survey/research questions and study stimuli. Focus groups and/or IDIs
with a sample of the target audience will allow FDA to refine the
survey/research questions and study stimuli while they are still in the
developmental stage. FDA will collect, and interpret information
gathered through this generic clearance in order to: (1) Better
understand characteristics of the target audience--its perceptions,
knowledge, attitudes, beliefs, and behaviors--and use these in the
development of appropriate survey/research questions, study stimuli, or
communications; (2) more efficiently and effectively design survey/
research questions and study stimuli; and (3) more efficiently and
effectively design experimental studies.
FDA is requesting approval of an extension of this generic
clearance for collecting information using qualitative methods (i.e.,
individual interviews, small group discussions, and focus groups) for
studies involving all tobacco products regulated by FDA. This
information will be used as a first step to explore concepts of
interest and assist in the development of quantitative study proposals,
complementing other important research efforts in the Agency. This
information may also be used to help identify and develop communication
messages, which may be used in education campaigns. Focus groups play
an important role in gathering information because they allow for an
in-depth understanding of individuals' attitudes, beliefs, motivations,
and feelings. Focus group
[[Page 61001]]
research serves the narrowly defined need for direct and informal
public opinion on a specific topic.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of interview Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
In-Person Individual In-depth 1,092 1 1,092 1............... 1,092
Interviews.
In-depth Interview (IDI) 1,800 1 1,800 0.083 (5 150
Screener. minutes).
Focus Group Screener.......... 19,385 1 19,385 0.25 (15 4,846
minutes).
Focus Group Interviews........ 5,897 1 5,897 1.5............. 8,846
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 14,934
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The number of respondents to be included in each new pretest may
vary, depending on the nature of the material or message being tested
and the target audience. Table 1 provides examples of the types of
studies that may be administered and estimated burden levels during the
3-year period. Time to read, view, or listen to the message being
tested is built into the ``Hours per Response'' figures. Our estimated
burden for the information collection reflects an overall increase of
5,641 hours and a corresponding increase of 16,585 responses. We
attribute this adjustment to the number of study responses used during
the current approval and now estimated for the next 3 years.
Dated: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21452 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P
