[Federal Register Volume 71, Number 38 (Monday, February 27, 2006)]
[Notices]
[Pages 9828-9829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0443]


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 March 
29, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (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

    FDA will collect and use information gathered through the focus 
group vehicle. This information will be used to develop programmatic 
proposals, and as such, compliments other important research findings 
to develop these proposals. Focus groups do 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.
    Also, information from these focus groups will be used to develop 
policy and redirect resources, when necessary, to our constituents. If 
this information is not collected, a vital link in information 
gathering by FDA to develop policy and programmatic proposals will be 
missed causing further delays in policy and program development.
    In the Federal Register of November 25, 2005 (FR 70 71165), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received one comment, however it was not 
related to the information collection.
    Annually, FDA projects about 28 focus group studies using 286 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. To arrive at 
each center's estimated burden we multiplied the number of focus groups 
per study by the number of participants per group. (e.g., Center for 
Biologics Evaluation and Research (CBER): 5x9=45). We multiplied that 
total by the hours of duration for each group to arrive at the total 
burden hours. (e.g., CBER: 45x1.58=71.1).
    The total annual estimated burden imposed by this collection of 
information is 4,252 hours annually.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                No. of                    Hours of
                                                   No. of       Focus                     Duration
                                                   Focus        Groups       No. of       for Each
      FDA Center                Subject          Groups per    Sessions   Participants     Group     Total Hours
                                                   Study      Conducted     per Group    (Includes
                                                               Annually                  Screening)
----------------------------------------------------------------------------------------------------------------
Center for Biologics    May use focus groups              1            5             9         1.58           71
 Evaluation and          when appropriate
 Research
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Center for Drug         Varies (e.g., direct-            10          200             9         1.58        2,844
 Evaluation and          to-consumer Rx drug
 Research                promotion, physician
                         labeling of Rx drugs,
                         medication guides,
                         over-the-counter drug
                         labeling, risk
                         communication)
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Center for Devices and  Varies (e.g., FDA Seal            4           16             9         2.08          300
 Radiological Health     of Approval, patient
                         labeling, tampons, on-
                         line sales of medical
                         products, latex
                         gloves)
----------------------------------------------------------------------------------------------------------------
Center for Food Safety  Varies (e.g., food                8           40             9         1.58          569
 and Applied Nutrition   safety, nutrition,
                         dietary supplements,
                         and consumer
                         education)
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Center for Veterinary   Varies (e.g., animal              5           25             9         2.08          468
 Medicine                nutrition,
                         supplements, labeling
                         of animal Rx)
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[[Page 9829]]

 
Total                   ......................           28          286  ............         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.


    Dated: February 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-2726 Filed 2-24-06; 8:45 am]
BILLING CODE 4160-01-S