[Federal Register Volume 72, Number 198 (Monday, October 15, 2007)]
[Notices]
[Pages 58309-58310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0098]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Focus Groups 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.

DATES: Fax written comments on the collection of information by 
November 14, 2007.

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: 202-395-6974, or e-mailed to [email protected]. 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 the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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--(OMB Control 
Number 0910-0497)--Extension

    Focus groups provide an important role in gathering information 
because they allow for a more in-depth 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 
toolhave three major purposes:
     To obtain consumer information that is useful for 
developing variables and measures for quantitative studies,

[[Page 58310]]

     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.
    In the Federal Register of March 27, 2007 (72 FR 14279), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden for completing the forms for this 
collection of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                         Hours of
                                           No. of      No. of Focus       No. of       Duration for
    FDA Center            Subject           Focus     Groups Sessions  Participants     Each Group       Total
                                         Groups per      Conducted       per Group       (Includes       Hours
                                            Study        Annually                       Screening)
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Center for          May use focus                 1                 5             9              1.58         71
 Biologics           groups when
 Evaluation and      appropriate
 Research
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Center for Drug     Varies (e.g.,                10               200             9              1.58      2,844
 Evaluation and      direct-to-consumer
 Research            Rx drug promotion,
                     physician labeling
                     of Rx drugs,
                     medication guides,
                     over-the-counter
                     drug labeling,
                     risk
                     communication)
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Center for Devices  Varies (e.g., FDA             4                16             9              2.08        300
 and Radiological    Seal of Approval,
 Health              patient labeling,
                     tampons, online
                     sales of medical
                     products, latex
                     gloves)
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Center for Food     Varies (e.g., food            8                40             9              1.58        569
 Safety and          safety, nutrition,
 Applied Nutrition   dietary
                     supplements, and
                     consumer
                     education)
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Center for          Varies (e.g.,                 5                25             9              2.08        468
 Veterinary          animal nutrition,
 Medicine            supplements,
                     labeling of animal
                     Rx)
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Total               ...................          28               286             9              1.78      4,252
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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 28 focus group studies using 186 focus 
groups lasting an average of 1.78 hours each. FDA has allowed burden 
for unplanned focus groups to be completed so as not to restrict the 
agency's ability to gather information on public sentiment for its 
proposals in its regulatory as well as other programs.

    Dated: October 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20291 Filed 10-12-07; 8:45 am]
BILLING CODE 4160-01-S