Document ID: FDA-2023-N-1005-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration
Posted Date: 2023-10-19T04:00Z

[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72083-72084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1005]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Focus Groups and 
Interviews as Used by the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by November 20, 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 0910-0497. 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.

Focus Groups and Interviews as Used by the Food and Drug Administration

OMB Control No. 0910-0497--Extension

    FDA conducts focus groups and in-depth individual interviews on a 
variety of topics involving FDA-regulated products, including drugs, 
biologics, devices, food, tobacco products, and veterinary medicine.
    Focus groups are an important role in gathering information because 
they allow for a better understanding of consumers' attitudes, beliefs, 
motivations, and feelings than do quantitative studies and encourages 
interaction between participants.
    Individual interviews allow for a more comprehensive, in-depth 
information exchange where more insights are likely to be collected.
    Both focus groups and in-depth individual interviews serve the 
narrowly defined need for direct and informal opinion on a specific 
topic and, as a qualitative research tool, have three major purposes:
     To obtain consumer information that is useful for 
developing variables and measures for quantitative studies,
     To better understand consumers' attitudes and emotions in 
response to topics and concepts, and
     To further explore findings obtained from quantitative 
studies.
    FDA will use findings to test and refine ideas but will generally 
conduct further research before making important decisions, such as 
adopting new policies and allocating or redirecting significant 
resources to support these policies.
    Respondents to this collection of information will include members 
of the general public, healthcare professionals, the industry, and 
other stakeholders who are related to a product under FDA's 
jurisdiction. Inclusion and exclusion criteria will vary depending on 
the research topic.
    In the Federal Register of April 11, 2023 (88 FR 21680), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Three comments were received, two in support 
of the information collection, and one that did not address the 
elements of the PRA.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 72084]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Focus groups and individual in-depth interviews....................          12,000                1           12,000             1.75           21,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated burden for the information collection reflects an 
overall increase of 5,600 hours and a corresponding increase of 3,200 
responses. We have added individual in-depth interviews as a method of 
information gathering. In addition, we are consolidating ICR 0910-0677, 
``Focus Groups About Drug Products as Used by the Food and Drug 
Administration'' into this request for extension.

    Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23011 Filed 10-18-23; 8:45 am]
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