Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications, 22690-22691 [2018-10457]
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Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices
or Joanne Lipkin at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0987]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for the Collection of Qualitative Data
on Tobacco Products and
Communications
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by June 15,
2018.
DATES:
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 0910–0796. Also
include the FDA docket number found
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
17:34 May 15, 2018
Jkt 244001
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Generic Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications
[FR Doc. 2018–10414 Filed 5–15–18; 8:45 am]
AGENCY:
in brackets in the heading of this
document.
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
understand people’s knowledge and
perceptions about tobacco-related topics
before 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,
analyze, and interpret information
gathered through this generic clearance
in order to: (1) Better understand
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
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 this
new generic clearance for collecting
information through the use of
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 at FDA. 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 individual
attitudes, beliefs, motivations, and
feelings. Focus group research serves
the narrowly defined need for direct and
informal public opinion on a specific
topic. In the Federal Register of
November 17, 2017 (82 FR 54351), FDA
published a 60-day notice requesting
public comment on the proposed
collection of information. FDA received
one comment by a private citizen that
was PRA-related.
(Comment) The commenter stated that
FDA should use the data we have
collected in the past instead of
collecting new information. The
comment does not go in detail or
provide any alternatives.
(Response) This collection is a
valuable tool for conducting research.
The studies FDA has conducted through
this collection of information have been
essential in helping FDA meet its
mission as a science-based regulatory
agency and implementing the Family
Smoking Prevention and Tobacco
Control Act (Pub. L. 111–31). Future
submissions submitted under this
generic clearance will continue to assist
FDA in its mission to protect and
promote public health.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\16MYN1.SGM
16MYN1
Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices
22691
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of interview
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
In-Person Individual IDIs ...........................................
IDI Screener ...............................................................
Focus Group Interviews .............................................
Focus Group Screener ..............................................
Usability Testing ........................................................
Usability Testing Screener .........................................
1,092
1,800
4,701
3,996
2,322
2,028
1
1
1
1
1
1
1,092
1,800
4,701
3,996
2,322
2,028
1 ...............................
.083 (5 minutes) ......
1.5 ............................
.25 (15 minutes) ......
.5 (30 minutes) ........
.083 (5 minutes) ......
1,092
149
7,052
999
1,161
168
Total ....................................................................
........................
........................
........................
..................................
10,621
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 a 3-year period. Time to
read, view, or listen to the message
being tested is built into the ‘‘Hours per
Response’’ figures.
FDA has updated the estimated
burden that was published in the 60-day
notice. The estimated burden for this
collection has increased by 4,437 hours
from 6,184 to 10,621. FDA attributes
this increase to adding usability testing,
and increasing the overall number of
studies planned the next 3 years.
Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10457 Filed 5–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990—New]
Office of the Secretary, HHS.
Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before June 15, 2018.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:34 May 15, 2018
Jkt 244001
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Trafficking
Victim Assistance Program Social
Network Analysis—Network Survey.
Type of Collection: New.
OMB No. 0990–NEW—Office of the
Assistant Secretary for Planning and
Evaluation—Administration for
Children and Families’ Trafficking
Victim Assistance Program.
SUPPLEMENTARY INFORMATION:
Abstract
Agency Information Collection
Request. 30-Day Public Comment
Request
ACTION:
comments or requesting information,
please include the document identifier
0990—New—30D and project title for
reference.
The Office of the Assistant Secretary
for Planning and Evaluation (ASPE), in
partnership with the Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS) is requesting Office of
Management and Budget (OMB)
approval for a new information
collection request titled, ‘‘Trafficking
Victim Assistance Program (TVAP)
Social Network Analysis—Network
Survey.’’ Under the guidance of ASPE
and ACF, a contractor is carrying out
this assessment. The data collected and
analyzed under this submission will
help HHS better understand the type
and extent of the relationship between
the TVAP grantees, TVAP subrecipients,
and other service providers operating in
TVAP subrecipient areas. It will also
help illuminate each grantee’s and
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Fmt 4703
Sfmt 4703
subrecipient’s types and number of
services provided, estimated costs of
services, service coordination between
grantees or subrecipients and other
services providers, and type and
strength of relationships between
grantees and subrecipients. This
information will enable HHS to
understand the structure of the grantee/
subrecipient network and inform
recommendations for more efficient
network management and distribution
of support.
TVAP, as authorized by the
Trafficking Victims Protection Act of
2000, provides comprehensive case
management services to foreign-born
victims of human trafficking residing in
the United States. Since its inception,
TVAP funding and infrastructure have
remained relatively unchanged: Services
are paid on a per capita basis, and funds
are managed through three primary
grantees that enter into cooperative
agreements with service providers
(subrecipients). Given the changing
landscape and the greater understanding
of the nature and extent of trafficking,
HHS is undertaking a program
assessment to understand whether any
efficiencies can be gained in the
program administration and structure.
To supplement an earlier fiscal year
2018 assessment to solicit qualitative
feedback from a range of program
stakeholders, the information collected
for this program survey aims to help
HHS determine if efficiencies can be
gained through improved coordination
among TVAP grantees, TVAP
subrecipients, and other service
providers.
Data will be collected through an
electronic survey of fiscal year 2016
TVAP grantees and subrecipients. Key
staff at grantee sites and subrecipient
organizations will complete a selfadministered online survey that will
include questions about each
respondent’s services provided,
estimated costs of services, service
coordination between grantees or
subrecipients, and type and strength of
E:\FR\FM\16MYN1.SGM
16MYN1
]]>Agencies
[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Notices]
[Pages 22690-22691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10457]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0987]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 (PRA).
DATES: Fax written comments on the collection of information by June
15, 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 0910-0796.
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 collection of information to OMB for
review and clearance.
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
understand people's knowledge and perceptions about tobacco-related
topics before 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, analyze, 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 this new generic clearance for
collecting information through the use of 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 at FDA. 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 individual attitudes, beliefs, motivations, and
feelings. Focus group research serves the narrowly defined need for
direct and informal public opinion on a specific topic. In the Federal
Register of November 17, 2017 (82 FR 54351), FDA published a 60-day
notice requesting public comment on the proposed collection of
information. FDA received one comment by a private citizen that was
PRA-related.
(Comment) The commenter stated that FDA should use the data we have
collected in the past instead of collecting new information. The
comment does not go in detail or provide any alternatives.
(Response) This collection is a valuable tool for conducting
research. The studies FDA has conducted through this collection of
information have been essential in helping FDA meet its mission as a
science-based regulatory agency and implementing the Family Smoking
Prevention and Tobacco Control Act (Pub. L. 111-31). Future submissions
submitted under this generic clearance will continue to assist FDA in
its mission to protect and promote public health.
FDA estimates the burden of this collection of information as
follows:
[[Page 22691]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of interview Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-Person Individual IDIs.................... 1,092 1 1,092 1........................................ 1,092
IDI Screener................................. 1,800 1 1,800 .083 (5 minutes)......................... 149
Focus Group Interviews....................... 4,701 1 4,701 1.5...................................... 7,052
Focus Group Screener......................... 3,996 1 3,996 .25 (15 minutes)......................... 999
Usability Testing............................ 2,322 1 2,322 .5 (30 minutes).......................... 1,161
Usability Testing Screener................... 2,028 1 2,028 .083 (5 minutes)......................... 168
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 10,621
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 a
3-year period. Time to read, view, or listen to the message being
tested is built into the ``Hours per Response'' figures.
FDA has updated the estimated burden that was published in the 60-
day notice. The estimated burden for this collection has increased by
4,437 hours from 6,184 to 10,621. FDA attributes this increase to
adding usability testing, and increasing the overall number of studies
planned the next 3 years.
Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10457 Filed 5-15-18; 8:45 am]
BILLING CODE 4164-01-P
