Document ID: FDA-2010-N-0594-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Focus Groups as Usedby Food and Drug Administration (All Food and Drug Administration Regulated Products)
Posted Date: 2010-11-30T05:00Z

[Federal Register: November 30, 2010 (Volume 75, Number 229)]
[Notices]               
[Page 74061-74062]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no10-95]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on focus groups as used by FDA to 
gauge public opinion on all FDA-regulated products.

DATES: Submit either electronic or written comments on the collection 
of information by January 31, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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.
    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 or operating and maintenance costs associated with this collection of information.

[[Page 74062]]

    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: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30037 Filed 11-29-10; 8:45 am]
BILLING CODE 4160-01-P