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, 31328-31330 [2021-12256]
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31328
Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices
address (§ 1210.22). Section 1210.20
requires that an application for a permit
to ship or transport milk or cream into
the United States be made by the actual
shipper. Section 1210.23 allows permits
to be granted based on certificates from
accredited officials.
Description of Respondents:
Respondents include foreign dairy farms
and plants engaged in transporting milk
and/or cream into the United States.
Respondents are from the private sector
(for-profit businesses).
In the Federal Register of November
4, 2020 (85 FR 70182), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR
section
1210.11
1210.12
1210.13
1210.14
...........
...........
...........
...........
Number of
responses per
respondent
Number of
respondents
Form FDA No.
Total annual
responses
Average burden
per response
Total hours
1
1
1
1
200
1
1
1
200
1
1
1
1.5 ...................................
0.5 (30 minutes) .............
0.5 (30 minutes) .............
2 ......................................
300
0.5
0.5
2
1
1
1
0.5 (30 minutes) .............
0.5
1210.23 ...........
1996/Farm Inspection Report .................................
1995/Report of Physical Examination of Cows ......
1994/Report of Tuberculin Tests of Cattle .............
1997/Score Card for Sanitation Inspections of Milk
Plants.
1993/Application for Permit to Ship or Transport
Milk and/or Cream into United States.
1815/Certificate/Transmittal for an Application .......
1
1
1
0.5 (30 minutes) .............
0.5
Total ........
.................................................................................
........................
........................
........................
.........................................
304
1210.20 ...........
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
1210.15 Pasteurization; Equipment and Methods ...............................
jbell on DSKJLSW7X2PROD with NOTICES
1 There
Number of
records per
recordkeeper
1
Total annual
records
1
Average burden
per recordkeeping
1
Total hours
0.05 (3 minutes) .............
0.05
are no capital costs or operating and maintenance costs associated with this collection of information.
The Secretary of Health and Human
Services has the discretion to allow
Form FDA 1815, a duly certified
statement signed by an accredited
official of a foreign government, to be
submitted in lieu of Forms FDA 1994
and 1995. In the past, Form FDA 1815
has been submitted in lieu of these
forms. Because we have not received
any Forms FDA 1994 or 1995 in the last
3 years, we assume no more than 1 will
be submitted annually.
No burden has been estimated for the
tagging requirement in § 1210.22
because the information on the tag is
either supplied by us (permit number)
or is disclosed to third parties as a usual
and customary part of the shipper’s
normal business activities (type of
product, shipper’s name and address).
Under 5 CFR 1320.3(c)(2), the public
disclosure of information originally
supplied by the Federal Government to
the recipient for the purpose of
disclosure to the public is not subject to
review by OMB under the PRA. Under
5 CFR 1320.3(b)(2), the time, effort, and
financial resources necessary to comply
with a collection of information are
excluded from the burden estimate if
the reporting, recordkeeping, or
disclosure activities needed to comply
are usual and customary because they
would occur in the normal course of
business activities.
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19:14 Jun 10, 2021
Jkt 253001
Based on a review of the information
collection since our last OMB approval,
we have decreased our burden estimate.
The estimated number of respondents
and hours per response are based on our
experience with the import milk permit
program and the average number of
import milk permit holders over the
past 3 years. However, we have not
received any responses in the last 3
years. Therefore, we estimate that one or
fewer to be submitted annually.
Although we have not received any
responses in the last 3 years, we believe
these information collection provisions
should be extended to provide for the
potential future need for a milk
importer.
Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12263 Filed 6–10–21; 8:45 am]
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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.
The Food and Drug
Administration (FDA or Agency) 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 July 12,
2021.
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
SUMMARY:
E:\FR\FM\11JNN1.SGM
11JNN1
Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0796. Also include
the FDA docket number found in
brackets in the heading of this
document.
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.
FOR FURTHER INFORMATION CONTACT:
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:
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 indepth 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 indepth understanding of
individuals’ attitudes, beliefs,
motivations, and feelings. Focus group
research serves the narrowly defined
need for direct and informal public
opinion on a specific topic.
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
31329
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.
In the Federal Register of September
29, 2020 (85 FR 60999), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received two
comments; however, only one was PRArelated.
(Comment) The comment expressed
support for FDA’s collection of
qualitative research on tobacco
products. The comment stated further
that while FDA indicates that this
research will meet the ‘‘narrowly
defined need for direct and informal
public opinion on a specific topic,’’ the
Agency has recently used this work for
broader purposes, including informing
the Proposed Rule for graphic health
warnings.’’
(Response) FDA appreciates the
support for conducting qualitative
research on tobacco products. FDA
disagrees with the comment suggesting
that the Agency has used its qualitative
generic collection for ‘‘broader
purposes’’ than contemplated by the
generic collection. Review of a generic
collection occurs in two stages: (1) A
full PRA review of the generic clearance
ICR, which includes the general
approach and methodology, at least
once every 3 years and (2) an expedited
review of the individual collections that
fall within the scope of the generic
clearance. OMB reviewed the individual
collection[s] that this comment cites and
approved the collection, having
determined that it was appropriately
within the scope of the generic
clearance.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
jbell on DSKJLSW7X2PROD with NOTICES
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 Screener ........................................................................
Focus Group Interviews .......................................................................
1,092
1,800
19,385
5,897
1
1
1
1
1,092
1,800
19,385
5,897
1 ......................................
0.083 (5 minutes) ...........
0.25 (15 minutes) ...........
1.5 ...................................
1,092
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.
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31330
Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices
Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12256 Filed 6–10–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the COVID–19 Health Equity
Task Force
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice of meeting.
AGENCY:
As required by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services (HHS) is hereby giving notice
that the COVID–19 Health Equity Task
Force (Task Force) will hold a virtual
meeting on June 25, 2021. The purpose
of this meeting is to consider interim
recommendations addressing the
inequities and the impact of longCOVID or Post-Acute Sequelae of
SARS–CoV–2 infection (PASC), and
access to personal protection
equipment, testing, and therapeutics
that are related to this pandemic. This
meeting is open to the public and will
be live-streamed at www.hhs.gov/live.
Information about the meeting will be
posted on the HHS Office of Minority
Health website:
www.minorityhealth.hhs.gov/
healthequitytaskforce/ prior to the
meeting.
DATES: The Task Force meeting will be
held on Friday, June 25, 2021, from 2
p.m. to approximately 6 p.m. ET (date
and time are tentative and subject to
change). The confirmed time and
agenda will be posted on the COVID–19
Health Equity Task Force web page:
www.minorityhealth.hhs.gov/
healthequitytaskforce/ when this
information becomes available.
FOR FURTHER INFORMATION CONTACT:
Samuel Wu, Designated Federal Officer
for the Task Force; Office of Minority
Health, Department of Health and
Human Services, Tower Building, 1101
Wootton Parkway, Suite 100, Rockville,
Maryland 20852. Phone: 240–453–6160;
email: COVID19HETF@hhs.gov.
SUPPLEMENTARY INFORMATION:
Background: The COVID–19 Health
Equity Task Force (Task Force) was
established by Executive Order 13995,
dated January 21, 2021. The Task Force
is tasked with providing specific
recommendations to the President,
through the Coordinator of the COVID–
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SUMMARY:
VerDate Sep<11>2014
19:14 Jun 10, 2021
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19 Response and Counselor to the
President (COVID–19 Response
Coordinator), for mitigating the health
inequities caused or exacerbated by the
COVID–19 pandemic and for preventing
such inequities in the future. The Task
Force shall submit a final report to the
COVID–19 Response Coordinator
addressing any ongoing health
inequities faced by COVID–19 survivors
that may merit a public health response,
describing the factors that contributed to
disparities in COVID–19 outcomes, and
recommending actions to combat such
disparities in future pandemic
responses.
The meeting is open to the public and
will be live-streamed at www.hhs.gov/
live. No registration is required. A
public comment session will be held
during the meeting. Pre-registration is
required to provide public comment
during the meeting. To pre-register,
please send an email to
COVID19HETF@hhs.gov and include
your name, title, and organization by
close of business on Friday, June 18,
2021. Comments will be limited to no
more than three minutes per speaker
and should be pertinent to the meeting
discussion. Individuals are encouraged
to provide a written statement of any
public comment(s) for accurate minutetaking purposes. If you decide you
would like to provide public comment
but do not pre-register, you may submit
your written statement by emailing
COVID19HETF@hhs.gov no later than
close of business on Thursday, July 1,
2021. Individuals who plan to attend
and need special assistance, such as
sign language interpretation or other
reasonable accommodations, should
contact: COVID19HETF@hhs.gov and
reference this meeting. Requests for
special accommodations should be
made at least 10 business days prior to
the meeting.
Dated: June 8, 2021.
Samuel Wu,
Designated Federal Officer, COVID–19 Health
Equity Task Force.
[FR Doc. 2021–12320 Filed 6–10–21; 8:45 am]
BILLING CODE 4150–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
PO 00000
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The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Nursing Research Initial Review Group.
Date: June 24–25, 2021.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Nursing
Research, 6701 Democracy Boulevard,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Cheryl Nordstrom, Ph.D.,
Scientific Review Officer, National Institute
of Nursing Research, National Institutes of
Health, 6701 Democracy Blvd., Suite 703H,
Bethesda, MD 20892, (301) 827–1499,
cheryl.nordstrom@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: June 7, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–12234 Filed 6–10–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Multi-Omics
Studies for Osteoporosis.
Date: July 9, 2021.
Time: 12:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31328-31330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12256]
-----------------------------------------------------------------------
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 or Agency) 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 July 12, 2021.
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
[[Page 31329]]
Review--Open for Public Comments'' or by using the search function. The
OMB control number for this information collection is 0910-0796. Also
include the FDA docket number found in brackets in the heading of this
document.
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: 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
indepth 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
indepth understanding of individuals' attitudes, beliefs, motivations,
and feelings. Focus group research serves the narrowly defined need for
direct and informal public opinion on a specific topic.
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.
In the Federal Register of September 29, 2020 (85 FR 60999), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments; however, only one
was PRA-related.
(Comment) The comment expressed support for FDA's collection of
qualitative research on tobacco products. The comment stated further
that while FDA indicates that this research will meet the ``narrowly
defined need for direct and informal public opinion on a specific
topic,'' the Agency has recently used this work for broader purposes,
including informing the Proposed Rule for graphic health warnings.''
(Response) FDA appreciates the support for conducting qualitative
research on tobacco products. FDA disagrees with the comment suggesting
that the Agency has used its qualitative generic collection for
``broader purposes'' than contemplated by the generic collection.
Review of a generic collection occurs in two stages: (1) A full PRA
review of the generic clearance ICR, which includes the general
approach and methodology, at least once every 3 years and (2) an
expedited review of the individual collections that fall within the
scope of the generic clearance. OMB reviewed the individual
collection[s] that this comment cites and approved the collection,
having determined that it was appropriately within the scope of the
generic clearance.
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 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 0.083 (5 minutes)......................... 150
Focus Group Screener........................ 19,385 1 19,385 0.25 (15 minutes)......................... 4,846
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.
[[Page 31330]]
Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12256 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P
