[Federal Register: March 9, 2004 (Volume 69, Number 46)]
[Notices]               
[Page 11019-11021]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr04-86]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0508]

 
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.

-----------------------------------------------------------------------

[[Page 11020]]

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 April 
8, 2004.

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: JonnaLynn P. 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.
    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.
    In the Federal Register of November 24, 2003 (68 FR 65938), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 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
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 11021]]

    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: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5194 Filed 3-8-04; 8:45 am]

BILLING CODE 4160-01-S