[Federal Register Volume 67, Number 169 (Friday, August 30, 2002)]
[Notices]
[Pages 55854-55855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22284]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0159]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

[[Page 55855]]


DATES: Submit written comments on the collection of information by 
September 30, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Mark L. Pincus, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1471.

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--New 
Collection

    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 May 24, 2002 (67 FR 36613), the agency 
requested comments on the proposed collection of information. FDA 
received four comments, but they did not pertain to the information 
collection though one heartily supported the use of focus groups as an 
instrument to help FDA better understand how well respondents 
comprehend health issues.
    FDA estimates the burden for completing the forms for this 
collection of information as follows:
    The total annual estimated burden imposed by this collection of 
information is 2,884 hours annually.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                        No. of                  Hours of
                                                              No. of    Focus                   Duration
                                                               Focus    Group      Number of    for Each   Total
           Center                        Subject              Groups   Sessions  Participants     Group    Hours
                                                                per   Conducted    per Group    (includes
                                                               Study   Annually                screening)
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Center for Biologics         May use focus groups when            1        5            9         1.58       71
 Evaluation and Research.     appropriate.
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Center for Drug Evaluation   Varies (e.g., direct-to-            10      100            9         1.58     1,422
 and Research.                consumer Rx drug promotion,
                              physician labeling of Rx
                              drugs, medication guides, over-
                              the-counter drug labeling,
                              risk communication).
----------------------------------------------------------------------------------------------------------------
Center for Devices and       Varies (e.g., FDA Seal of            5       25            9         2.08      468
 Radiological Health.         Approval, patient labeling,
                              tampons, on-line sales of
                              medical products, latex
                              gloves).
----------------------------------------------------------------------------------------------------------------
Center for Food Safety and   Varies (e.g., food safety,           8       32            9         1.58      455
 Applied Nutrition.           nutrition, dietary
                              supplements, and consumer
                              education).
----------------------------------------------------------------------------------------------------------------
Center for Veterinary        Varies (e.g., food safety,           5       25            9         2.08      468
 Medicine.                    labeling, cosmetic safety and
                              labeling).
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Total                                                            29      187                      1.99     3,352
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\1\There are no capital costs or operating and maintenance costs associated with this collection.

    Annually, FDA projects about 29 focus group studies using 187 focus 
groups lasting an average of 1.99 hours each. We have 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: August 26, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-22284 Filed 8-29-02; 8:45 am]
BILLING CODE 4160-01-S