Notice2023-23011
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
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
October 19, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 201 (Thursday, October 19, 2023)</title>
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[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72083-72084]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 0910-0497. 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,
<a href="/cdn-cgi/l/email-protection#cd9d9f8c9eb9acabab8daba9ace3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="68383a293b1c090e0e280e0c094600001b460f071e">[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.
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:
<bullet> To obtain consumer information that is useful for
developing variables and measures for quantitative studies,
<bullet> To better understand consumers' attitudes and emotions in
response to topics and concepts, and
<bullet> 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]
BILLING CODE 4164-01-P
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