Document ID: FDA-2007-N-0444-0004
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: 2014-06-05T04:00Z

[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Pages 32555-32556]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13016]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0444]

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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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: Fax written comments on the collection of information by July 7, 
2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0497. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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 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.
    In the Federal Register of February 18, 2014 (79 FR 9222), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 32556]]

                                                     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.............................................           1,440                1            1,440             1.75            2,520
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Annually, FDA projects about 20 focus group studies using 160 focus 
groups with an average of 9 persons per group, and lasting an average 
of 1.75 hours each. FDA is requesting this burden for unplanned focus 
groups so as not to restrict the Agency's ability to gather information 
on public sentiment of its proposals in its regulatory and 
communications programs.

    Dated: May 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13016 Filed 6-4-14; 8:45 am]
BILLING CODE 4160-01-P