Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed, 21193-21195 [2023-07441]
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21193
Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Notices
• Collect the number of newly
enrolled and continuing families being
served;
• Number of home visits;
• Track and improve the quality of
benchmark measures data submitted by
the tribal grantees;
• Improve program monitoring and
oversight;
• Improve rigorous data analyses that
help to assess the effectiveness of the
programs and enable ACF to better
monitor projects;
• Ensure adequate and timely
reporting of program data to relevant
federal agencies and stakeholders
including Congress and members of the
public; and
• Collect data on caseload capacity,
retention and attrition of enrolled
families and the retention and attrition
of program staff on a quarterly basis.
Overall, this information collection
will provide valuable information to
HHS that will guide understanding of
the Tribal MIECHV Program and the
provision of technical assistance to
Tribal MIECHV Program grantees.
Respondents: Tribal MIECHV Program
Grantees.
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Annual
number of
responses per
respondent
55
55
55
1
1
4
Tribal MIECHV Demographic and Service Utilization Data Form ...................
Tribal MIECHV Performance Measures Form .................................................
Tribal MIECHV Quarterly Performance Report ...............................................
Estimated Total Annual Burden
Hours: 33,825.
Comments: HHS specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Authority: Section 511 of Title V of
the Social Security Act
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–07462 Filed 4–7–23; 8:45 am]
BILLING CODE 4184–77–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2023–N–1157]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for Qualitative Data To Support Social
and Behavioral Research for Food,
Dietary Supplements, Cosmetics, and
Animal Food and Feed
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:13 Apr 07, 2023
Jkt 259001
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 the collection of
information which allows the
submission of individual generic
requests for obtaining qualitative data to
support social and behavioral research
for food, dietary supplements,
cosmetics, and animal food and feed.
DATES: Either electronic or written
comments on the collection of
information must be submitted by June
9, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 9, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
Average
burden hours
per response
317
288
2.5
Annual burden
hours
17,435
15,840
550
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’’).
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–
2023–N–1157 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Generic
E:\FR\FM\10APN1.SGM
10APN1
ddrumheller on DSK120RN23PROD with NOTICES1
21194
Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Notices
Clearance for Qualitative Data To
Support Social and Behavioral Research
for Food, Dietary Supplements,
Cosmetics, and Animal Food and Feed.’’
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
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:
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.
VerDate Sep<11>2014
18:13 Apr 07, 2023
Jkt 259001
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.
SUPPLEMENTARY INFORMATION:
Generic Clearance for Qualitative Data
To Support Social and Behavioral
Research for Food, Dietary
Supplements, Cosmetics, and Animal
Food and Feed
OMB Control Number 0910–0891—
Extension
The Office of Management and
Budget’s (OMB) Office of Information
and Regulatory Affairs (OIRA) has
issued memoranda that provides an
overview of administrative flexibilities
available to assist agencies in complying
with their statutory obligations under
the PRA. Among these flexibilities is
use of a generic clearance for certain
information collection activities. A
generic clearance may be appropriate
when (1) the need for the data collection
can be evaluated in advance, as part of
the review of the proposed plan, but (2)
the Agency cannot determine the details
of the specific individual collections
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
until a later time. Generic clearances
cover collections that are voluntary,
low-burden, and uncontroversial.
This generic clearance supports
research intended to help CFSAN
understand stakeholders’ perceptions,
attitudes, motivations, and behaviors.
Understanding these perceptions,
attitudes, motivations, and behaviors
plays an important role in improving
FDA’s communications which impact
these various stakeholders and assists in
the development of quantitative study
proposals to complement other
important research efforts in the
Agency.
To ensure that communications
activities have the highest effect, we
will conduct research and studies
relating to the control and prevention of
disease and the safety and health of the
public. FDA is requesting OMB
approval for the use of this generic
collection of information that allows
FDA to use qualitative social/behavioral
science data collection techniques (i.e.,
individual in-depth interviews (IDIs),
small group discussions, focus groups,
and observations) to better understand
stakeholders’ perceptions, attitudes,
motivations, and behaviors regarding
various issues associated with food and
cosmetic products, dietary supplements,
and animal food and feed.
Understanding these consumers’,
manufacturers’, and producers’
perceptions, attitudes, motivations, and
behaviors plays an important role in
improving FDA’s communications that
impact these various stakeholders and
in assisting in the development of
quantitative study proposals,
complementing other important
research efforts in the Agency.
To obtain approval for an individual
generic submission collection that meets
the conditions of this generic clearance,
an abbreviated supporting statement
will be submitted to OMB along with
supporting documentation (e.g., a copy
of the interview or moderator guide,
screening questionnaire).
Selection for potential respondents is
done via a screening process to match
the best possible respondent to each
individual generic submission.
Respondents to individual requests
made under the generic clearance, once
approved by OMB, may include a wide
range of consumers and other FDA
stakeholders, such as producers and
manufacturers who are regulated under
FDA-regulated food and cosmetic
products, dietary supplements, and
animal food and feed. Participation is
voluntary.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\10APN1.SGM
10APN1
Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Notices
21195
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of interview
Average
burden per
response
Total annual
responses
Total hours
Individual In-Depth Interview Screening ..................................................
Individual In-Depth Interviews ..................................................................
Focus Group/Small Group Participant Screening ....................................
Focus Groups/Small Group Discussion ...................................................
Observation Screening .............................................................................
Observations ............................................................................................
4,800
400
10,800
3,600
720
144
1
1
1
1
1
1
4,800
400
10,800
3,600
720
144
.08 (5 minutes) ...........
1 ..................................
.08 (5 minutes) ...........
1.5 ...............................
.08 (5 minutes) ...........
2 ..................................
384
400
864
5,400
58
288
Total ..................................................................................................
........................
........................
20,464
.....................................
7,394
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Current estimates are based on both
historical numbers of participants from
past projects as well as estimates for
projects to be conducted in the next 3
years. The collections we have
conducted under this generic collection
of information have informed and
helped us better understand stakeholder
perceptions, attitudes, motivations, and
behaviors to help us improve our
communications to them.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: April 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0895]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Imports and
Electronic Import Entries
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 information
collection associated with our imports
program.
SUMMARY:
VerDate Sep<11>2014
18:13 Apr 07, 2023
Jkt 259001
Either electronic or written
comments on the collection of
information must be submitted by June
9, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 9, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
[FR Doc. 2023–07441 Filed 4–7–23; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
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’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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–
2023–N–0895 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Imports
and Electronic Import Entries.’’
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
E:\FR\FM\10APN1.SGM
10APN1
]]>Agencies
[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Notices]
[Pages 21193-21195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07441]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1157]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for Qualitative Data To Support
Social and Behavioral Research for Food, Dietary Supplements,
Cosmetics, and Animal Food and Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 the collection of information
which allows the submission of individual generic requests for
obtaining qualitative data to support social and behavioral research
for food, dietary supplements, cosmetics, and animal food and feed.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 9, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 9, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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'').
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-2023-N-1157 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic
[[Page 21194]]
Clearance for Qualitative Data To Support Social and Behavioral
Research for Food, Dietary Supplements, Cosmetics, and Animal Food and
Feed.'' 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: 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: 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 Qualitative Data To Support Social and Behavioral
Research for Food, Dietary Supplements, Cosmetics, and Animal Food and
Feed
OMB Control Number 0910-0891--Extension
The Office of Management and Budget's (OMB) Office of Information
and Regulatory Affairs (OIRA) has issued memoranda that provides an
overview of administrative flexibilities available to assist agencies
in complying with their statutory obligations under the PRA. Among
these flexibilities is use of a generic clearance for certain
information collection activities. A generic clearance may be
appropriate when (1) the need for the data collection can be evaluated
in advance, as part of the review of the proposed plan, but (2) the
Agency cannot determine the details of the specific individual
collections until a later time. Generic clearances cover collections
that are voluntary, low-burden, and uncontroversial.
This generic clearance supports research intended to help CFSAN
understand stakeholders' perceptions, attitudes, motivations, and
behaviors. Understanding these perceptions, attitudes, motivations, and
behaviors plays an important role in improving FDA's communications
which impact these various stakeholders and assists in the development
of quantitative study proposals to complement other important research
efforts in the Agency.
To ensure that communications activities have the highest effect,
we will conduct research and studies relating to the control and
prevention of disease and the safety and health of the public. FDA is
requesting OMB approval for the use of this generic collection of
information that allows FDA to use qualitative social/behavioral
science data collection techniques (i.e., individual in-depth
interviews (IDIs), small group discussions, focus groups, and
observations) to better understand stakeholders' perceptions,
attitudes, motivations, and behaviors regarding various issues
associated with food and cosmetic products, dietary supplements, and
animal food and feed. Understanding these consumers', manufacturers',
and producers' perceptions, attitudes, motivations, and behaviors plays
an important role in improving FDA's communications that impact these
various stakeholders and in assisting in the development of
quantitative study proposals, complementing other important research
efforts in the Agency.
To obtain approval for an individual generic submission collection
that meets the conditions of this generic clearance, an abbreviated
supporting statement will be submitted to OMB along with supporting
documentation (e.g., a copy of the interview or moderator guide,
screening questionnaire).
Selection for potential respondents is done via a screening process
to match the best possible respondent to each individual generic
submission. Respondents to individual requests made under the generic
clearance, once approved by OMB, may include a wide range of consumers
and other FDA stakeholders, such as producers and manufacturers who are
regulated under FDA-regulated food and cosmetic products, dietary
supplements, and animal food and feed. Participation is voluntary.
FDA estimates the burden of this collection of information as
follows:
[[Page 21195]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Type of interview Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individual In-Depth Interview Screening...... 4,800 1 4,800 .08 (5 minutes).......................... 384
Individual In-Depth Interviews............... 400 1 400 1........................................ 400
Focus Group/Small Group Participant Screening 10,800 1 10,800 .08 (5 minutes).......................... 864
Focus Groups/Small Group Discussion.......... 3,600 1 3,600 1.5...................................... 5,400
Observation Screening........................ 720 1 720 .08 (5 minutes).......................... 58
Observations................................. 144 1 144 2........................................ 288
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Total.................................... .............. .............. 20,464 ......................................... 7,394
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Current estimates are based on both historical numbers of
participants from past projects as well as estimates for projects to be
conducted in the next 3 years. The collections we have conducted under
this generic collection of information have informed and helped us
better understand stakeholder perceptions, attitudes, motivations, and
behaviors to help us improve our communications to them.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: April 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07441 Filed 4-7-23; 8:45 am]
BILLING CODE 4164-01-P
