Document ID: FDA-2019-N-6098-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Focus Groups as
Used by the Food and Drug Administration (All Food and Drug
Administration-Regulated Products)
Posted Date: 2020-08-20T04:00Z

[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51450-51451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18243]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-6098]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Focus Groups as Used 
by the Food and Drug Administration (All Food and Drug Administration-
Regulated Products)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 51451]]

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.

DATES: Submit written comments (including recommendations) on the 
collection of information by September 21, 2020.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10:00 a.m.-12:00 
p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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.

Focus Groups as Used by the Food and Drug Administration (All FDA-
Regulated Products)

OMB Control Number 0910-0497--Extension

    FDA conducts focus group interviews on a variety of topics 
involving FDA-regulated products, including drugs, biologics, devices, 
food, tobacco, and veterinary medicine.
    Focus groups provide an important role in gathering information 
because they allow for a more indepth understanding of consumers' 
attitudes, beliefs, motivations, and feelings than do quantitative 
studies. Focus groups 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 focus group findings to test and refine their 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 January 8, 2020 (85 FR 916), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received three comments. FDA thanks the 
commenters for their comments and provides our response below. The 
first and second comments strongly support the proposed information 
collection related to focus groups used by the FDA. The third comment 
was not responsive to the four collection of information topics 
solicited and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                                      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 Group Interviews.............................................           8,800                1            8,800             1.75           15,400
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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 have made no adjustments to our burden 
estimate.

    Dated: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18243 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P