Notice2023-26043
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Qualitative Feedback on Agency Service Delivery
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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.
Full Text
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<title>Federal Register, Volume 88 Issue 226 (Monday, November 27, 2023)</title>
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[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82905-82906]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26043]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1554]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Qualitative Feedback
on Agency Service Delivery
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 December 27, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0697. 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,
<a href="/cdn-cgi/l/email-protection#4e1e1c0f1d3a2f28280e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="b8e8eaf9ebccd9dedef8dedcd996d0d0cb96dfd7ce">[email protected]</span></a>.
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.
Qualitative Feedback on Agency Service Delivery
OMB Control Number 0910-0697--Extension
FDA will garner qualitative customer and stakeholder feedback using
a variety of methods in order to gain useful insights into customer or
stakeholder perceptions, experiences, and expectations; provide an
early warning of issues with service; or focus attention on areas where
communication, training, or changes in operations might improve
delivery of products or services. These collections will allow for
ongoing, collaborative, and actionable communications between the
Agency and its customers and stakeholders. It will also allow feedback
to contribute directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance.
Respondents to this collection of information cover a broad range
of customers and stakeholders who have specific characteristics related
to certain products or services regulated by FDA. These stakeholders
include members of the general public, healthcare professionals,
industry, and others who have experience with a product under FDA's
jurisdiction.
In the Federal Register of May 25, 2023 (88 FR 33889), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but it was outside
the scope of the PRA.
FDA estimates the burden of this collection of information as
follows:
[[Page 82906]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Focus groups................................ 3,000 1 3,000 1.75...................................... 5,250
Customer comment cards/forms................ 1,500 1 1,500 0.25 (15 minutes)......................... 375
Small discussion groups..................... 800 1 800 1.75...................................... 1,400
Customer satisfaction surveys............... 20,000 1 20,000 0.33 (20 minutes)......................... 6,600
Usability studies........................... 1,100 1 1,100 1......................................... 1,100
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Total................................... .............. .............. .............. .......................................... 14,725
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we increased the number of respondents for
focus groups, customer comment cards/forms, customer satisfaction
surveys, and usability studies. This adjustment results in an overall
burden increase of 6,234 hours.
Dated: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26043 Filed 11-24-23; 8:45 am]
BILLING CODE 4164-01-P
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