[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82905-82906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26043]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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 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, 
[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.

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          14,725
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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