Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Satisfaction Surveys, 24992-24994 [2023-08640]
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24992
Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Guidance for Tribal
Temporary Assistance for Needy
Families Program (Office of
Management and Budget #0970–0157)
Office of Family Assistance;
Administration for Children and
Families; Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families (ACF) is
requesting a 3-year extension of the
form ACF–123: Guidance for the Tribal
Temporary Assistance for Needy
Families (TANF) Program (Office of
SUMMARY:
Management and Budget (OMB) #0970–
0157, expiration date: August 31, 2023).
There are minor clarifying changes
requested to the guidance.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements the Paperwork Reduction
Act of 1995, ACF is soliciting public
comment on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Identify all requests by the
title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: 42 U.S.C. 612 (section
412 of the Social Security Act) requires
each Indian tribe that elects to
administer and operate a TANF program
to submit a TANF Tribal Plan. This
request includes the renewal of the
guidance for completing the initial
Tribal TANF Plan. The TANF Tribal
Plan is a mandatory statement
submitted to the Secretary of United
States Department of Health and Human
Services (HHS) by the Indian tribe,
which consists of an outline of how the
Indian tribe’s TANF program will be
administered and operated. It is used by
the Secretary to determine whether the
plan is approvable and to determine that
the Indian tribe is eligible to receive a
TANF assistance grant. It is also made
available to the public. The renewal
includes minor edits, such as updating
hyperlinks and correcting typographical
errors. Additionally, the list of
requirements has been reformatted so
that it is easier to read and use.
Respondents: Indian tribes applying
to operate a TANF program and to
renew their Tribal Family Assistance
Plan.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Total
number of
responses per
respondent
Average
burden
hours per
response
Total
burden
hours
Annual
burden
hours
Guidance For The TANF Program ......................................
75
1
68
5,100
1,700
Estimated Total Annual Burden
Hours: 1,700.
Comments: The Department
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: 42 U.S.C. 612.
Mary B. Jones,
ACF/OPRE Certifying Officer.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1053]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Customer/Partner
Service Satisfaction Surveys
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
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 customer service
satisfaction surveys.
DATES: Either electronic or written
comments on the collection of
information must be submitted by June
26, 2023.
SUMMARY:
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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 26, 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.
ADDRESSES:
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
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Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices
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’’).
lotter on DSK11XQN23PROD with NOTICES1
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–1053 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Customer/Partner Service Satisfaction
Surveys.’’ 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
VerDate Sep<11>2014
16:47 Apr 24, 2023
Jkt 259001
‘‘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:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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)
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24993
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.
Customer/Partner Service Satisfaction
Surveys
OMB Control Number 0910–0360—
Extension
Under section 1003 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393), FDA is authorized to conduct
research and public information
programs about regulated products and
responsibilities of the Agency.
Executive Order 12862, entitled ‘‘Setting
Customer Service Standard,’’ directs
Federal Agencies that ‘‘provide
significant services directly to the
public’’ to ‘‘survey customers to
determine the kind and quality of
services they want and their level of
satisfaction with existing services.’’ FDA
is seeking to extend OMB approval to
conduct customer service satisfaction
surveys to implement Executive Order
12862. Participation in the surveys is
voluntary. This request covers
customer/partner (including State and
local governments) service satisfaction
surveys of regulated entities, such as
food processors; cosmetic, drug,
biologic, and medical device
manufacturers; animal drugs, animal
food and feed; tobacco products; and
consumers and health professionals.
FDA will use the information from
these surveys to identify strengths and
weaknesses in service to customers/
partners and to make improvements.
The surveys will measure timeliness,
appropriateness, clarity, and accuracy of
information, courtesy, and problem
resolution in the context of individual
programs.
FDA estimates conducting
approximately 20 customer/partner
service satisfaction surveys per year,
each requiring an average of 25 minutes
for review and completion. We estimate
respondents to these surveys to be
between 100 and 20,000 customers/
partners. Some of these surveys will be
repeats of earlier surveys for purposes of
monitoring customer/partner service
and developing long-term data.
Respondents to this collection of
information cover a broad range of
stakeholders who have experience with
certain products regulated by or services
provided by FDA.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Mail, telephone, web-based survey ................
1 There
Dated: April 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08640 Filed 4–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2022–N–2657]
85,000
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by May 25,
2023.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is ‘‘Food
and Drug Administration’s Study of
Assessing Physiological, Neural and
Self-Reported Response to Tobacco
ADDRESSES:
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Education Messages.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
OMB Control Number 0910–NEW
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration’s Study of Assessing
Physiological, Neural and SelfReported Response to Tobacco
Education Messages
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1
Food and Drug Administration’s Study
of Assessing Physiological, Neural and
Self-Reported Response to Tobacco
Education Messages
Food and Drug Administration
ACTION:
85,000
Total annual
responses
Average burden
per response
.42 (25 minutes) .................
Total hours
35,700
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last OMB approval of this
information collection request, FDA
submitted three requests to increase the
total burden hours. Therefore, this
request for extension of OMB approval
adjusts the number of respondents by an
increase of 30,000 and the total burden
hours by an increase of 21,950.
AGENCY:
Number of
responses per
respondent
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act granted FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products; to inform the public on
health-related issues; and to protect
public health by reducing tobacco use
and by preventing death and disease
caused by tobacco use.
FDA’s Center for Tobacco Products
(CTP) was created to carry out the
authorities granted under the Tobacco
Control Act, to educate the public about
the dangers of tobacco use and serve as
a public health resource for tobacco and
health information. Through CTP, FDA
researches, develops, and distributes
information about tobacco and health to
the public, professionals, various
branches of government, and other
interested groups nationwide using a
wide array of formats and media
channels. FDA’s ‘‘The Real Cost’’
campaign (https://www.fda.gov/tobaccoproducts/public-health-educationcampaigns/real-cost-campaign) uses
evidence-based paid media advertising
to highlight the negative health
consequences of tobacco use. To
develop the appropriate messaging to
inform the public, it is important for
FDA to conduct research to assess youth
and young adults’ perceptions of
tobacco use prevention messaging.
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The study of ‘‘Assessing
Physiological, Neural and Self-Reported
Response to Tobacco Education
Messages’’ is voluntary research.
Information obtained through this study
will primarily be used to assess the
performance of ads developed to reduce
tobacco initiation and use among at-risk
youth and young adults as part of CTP’s
‘‘The Real Cost’’ campaign.
Traditionally, message testing research
employs self-reported measures of
perceived effectiveness (e.g., an
individual’s perception that the ad
would make one less likely to use
tobacco), but research indicates that
while these self-reported measures are
useful, they may be imperfect proxies
for real world knowledge, attitude, and
behavior change. This imprecision
could lead message developers to select
less than optimal messages or costineffective strategies for widespread
dissemination.
Physiological and neural responses to
tobacco education messages offer an
innovative and useful supplement to
traditional self-report measures.
Indicators such as heart rate variability,
galvanic skin response, and facial
electromyography can assess arousal
and affective response to messages,
while tools such as eye tracking and
neuroimaging can measure attention
and levels of activation in key areas in
the brain associated with message
processing and message acceptance.
Research indicates that these techniques
can be more effective than self-report
measures at predicting ‘‘real world’’
tobacco education message
effectiveness.
There is a need for research that
implements these techniques to identify
the most effective tobacco prevention
and education message strategies.
Additionally, there is a need to
triangulate data collected through
physiological and neuroimaging-based
approaches with self-reported measures
to better understand how self-reported
measures can be implemented in order
to accurately predict knowledge,
attitude, and behavior change.
This study will recruit participants
from the Baltimore, Maryland area to
participate in an in-person study visit at
Johns Hopkins University Bloomberg
School of Public Health. Inclusion and
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]]>Agencies
[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24992-24994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08640]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1053]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Customer/Partner Service Satisfaction Surveys
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 customer service satisfaction surveys.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 26, 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 26, 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
[[Page 24993]]
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-1053 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Customer/Partner Service
Satisfaction Surveys.'' 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: 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.
Customer/Partner Service Satisfaction Surveys
OMB Control Number 0910-0360--Extension
Under section 1003 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 393), FDA is authorized to conduct research and public
information programs about regulated products and responsibilities of
the Agency. Executive Order 12862, entitled ``Setting Customer Service
Standard,'' directs Federal Agencies that ``provide significant
services directly to the public'' to ``survey customers to determine
the kind and quality of services they want and their level of
satisfaction with existing services.'' FDA is seeking to extend OMB
approval to conduct customer service satisfaction surveys to implement
Executive Order 12862. Participation in the surveys is voluntary. This
request covers customer/partner (including State and local governments)
service satisfaction surveys of regulated entities, such as food
processors; cosmetic, drug, biologic, and medical device manufacturers;
animal drugs, animal food and feed; tobacco products; and consumers and
health professionals.
FDA will use the information from these surveys to identify
strengths and weaknesses in service to customers/partners and to make
improvements. The surveys will measure timeliness, appropriateness,
clarity, and accuracy of information, courtesy, and problem resolution
in the context of individual programs.
FDA estimates conducting approximately 20 customer/partner service
satisfaction surveys per year, each requiring an average of 25 minutes
for review and completion. We estimate respondents to these surveys to
be between 100 and 20,000 customers/partners. Some of these surveys
will be repeats of earlier surveys for purposes of monitoring customer/
partner service and developing long-term data. Respondents to this
collection of information cover a broad range of stakeholders who have
experience with certain products regulated by or services provided by
FDA.
FDA estimates the burden of this collection of information as
follows:
[[Page 24994]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mail, telephone, web-based survey........ 85,000 1 85,000 .42 (25 minutes)............................. 35,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last OMB approval of this information collection request,
FDA submitted three requests to increase the total burden hours.
Therefore, this request for extension of OMB approval adjusts the
number of respondents by an increase of 30,000 and the total burden
hours by an increase of 21,950.
Dated: April 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08640 Filed 4-24-23; 8:45 am]
BILLING CODE 4164-01-P
