[Federal Register: November 24, 2003 (Volume 68, Number 226)]
[Notices]               
[Page 65938-65939]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no03-77]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0508]

 
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 
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. Policymakers can use focus group results to test 
and refine their ideas so they can conduct further research, as well 
as, 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 January 23, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: JonnaLynn P. Capezzuto, Office of 
Management Programs (HFA-250), Food and Drug Administration, 5600 
Fishers

[[Page 65939]]

Lane, Rockville, MD 20857, 301-827-4659.

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--(OMB Control 
Number 0910-0497)

    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 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 in table 1 of this document .
    The total annual estimated burden imposed by this collection of 
information is 2,830 hours annually.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                                                       Hours of
                            No. of Focus      No. of Focus           No. of          Duration for
   Center      Subject       Groups per      Groups Sessions    Participants per      Each Group     Total Hours
                               Study       Conducted Annually         Group           (includes
                                                                                      screening)
----------------------------------------------------------------------------------------------------------------
Center for   May use                   1                   5                   9             1.58            71
 Biologics    focus
 Evaluation   groups
 and          when
 Research     appropriat
              e
----------------------------------------------------------------------------------------------------------------
Center for   Varies                   10                 100                   9             1.58         1,422
 Drug         (e.g.,
 Evaluation   direct-to-
 and          consumer
 Research     Rx drug
              promotion,
              physician
              labeling
              of Rx
              drugs,
              medication
              guides,
              over-the-
              counter
              drug
              labeling,
              risk
              communicat
              ion
----------------------------------------------------------------------------------------------------------------
Center for   Varies                    4                  16                   9             2.08           300
 Devices      (e.g., FDA
 and          Seal of
 Radiologic   Approval,
 al Health    patient
              labeling,
              tampons,
              on-line
              sales of
              medical
              products,
              latex
              gloves
----------------------------------------------------------------------------------------------------------------
Center for   Varies                    8                  40                   9             1.58           569
 Food         (e.g.,
 Safety and   food
 Applied      safety,
 Nutrition    nutrition,
              dietary
              supplement
              s,
              consumer
              education)
----------------------------------------------------------------------------------------------------------------
Center for   Varies                    5                  25                   9             2.08           468
 Veterinary   (e.g.,
 Medicine     animal
              nutrition,
              supplement
              s,
              labeling
              of animal
              Rx)
----------------------------------------------------------------------------------------------------------------
Total        ...........              28                 186   ..................            1.78         2,830
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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: November 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29197 Filed 11-21-03; 8:45 am]

BILLING CODE 4160-01-S