[Federal Register Volume 67, Number 101 (Friday, May 24, 2002)]
[Notices]
[Pages 36613-36615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13163]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0159]


Agency Information Collection Activities; Proposed Collection; 
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 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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on focus groups as used by FDA. These focus 
groups gauge public opinion, and policymakers can use focus group 
findings to test and refine their ideas so they can conduct further 
research whose findings can be used to adopt new policies and to 
allocate or redirect significant resources to support these policies.

DATES: Submit written or electronic comments on the collection of 
information by July 23, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: 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: 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

[[Page 36614]]

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: (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

    FDA will collect and use information gathered through the focus 
group vehicle. This information will be used to develop programmatic 
proposals, and as such complements other important research findings to 
develop these proposals. Focus groups do 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.
    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.
    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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                                                                                                                           Hours of
                                                                 No. of Focus     No. of Focus          No. of         [chyph]Duration
            Center                         Subject                Groups per    Groups Sessions  [chyph]Participants    for Each Group     Total Hours
                                                                    Study          Conducted          per Group        ([chyph]includes
                                                                                [chyph]Annually                       [chyph]screening)
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Center for Biologics            May use focus groups when              1                5                  9                   1.58             71
 Evaluation and Research         appropriate
Center for Drug Evaluation and  Varies (e.g., direct-to-              10              100                  9                   1.58          1,422
 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, online 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 Medicine  Varies (e.g., food safety,             5               25                  9                   2.08            468
                                 labeling, cosmetic safety
                                 and labeling)
Total                           .............................         29              187        ...................           1.71          2,884
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 36615]]

    Annually, FDA projects about 29 focus group studies using 187 focus 
groups lasting an average of 1.71 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: May 14, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-13163 Filed 5-23-02; 8:45 am]
BILLING CODE 4160-01-S