
[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Notices]
[Pages 6802-6803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2665]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0594]


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 March 
10, 2011.

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 e-mailed 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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, e-mail: 
Jonnalynn.capezzuto@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

[[Page 6803]]

     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.
    In the Federal Register of November 30, 2010 (75 FR 74061), 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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                           Annual
                              Activity                                  Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         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: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2665 Filed 2-7-11; 8:45 am]
BILLING CODE 4160-01-P


