[Federal Register Volume 69, Number 42 (Wednesday, March 3, 2004)]
[Notices]
[Pages 10050-10051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4655]


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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.

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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 April 
2, 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 provide an important role in 
gathering information because they allow for a more in depth 
understanding of consumers' attitudes, beliefs, motivations, and 
feelings than 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.
    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.
    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.

[[Page 10051]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                      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            Group          (includes
                                                   Annually                           screening
----------------------------------------------------------------------------------------------------------------
Center for     May use focus    1              5                9                        1.58           71
 Biologics      groups when
 Evaluation     appropriate
 and Research
----------------------------------------------------------------------------------------------------------------
Center for     Varies (e.g.,    10             100              9                        1.58        1,422
 Drug           direct-to-
 Evaluation     consumer Rx
 and Research   drug
                promotion,
                physician
                labeling of Rx
                drugs,
                medication
                guides, over-
                the-counter
                drug labeling,
                risk
                communication
----------------------------------------------------------------------------------------------------------------
Center for     Varies (e.g.,    4              16               9                        2.08          300
 Devices and    FDA Seal of
 Radiological   Approval,
                patient
                labeling,
                tampons, on-
                line sales of
                medical
                products,
                latex gloves
----------------------------------------------------------------------------------------------------------------
Center for     Varies (e.g.,    8              40               9                        1.58          569
 Food Safety    food safety,
 and Applied    nutrition,
 Nutrition      dietary
                supplements,
                consumer
                education)
----------------------------------------------------------------------------------------------------------------
Center for     Varies (e.g.,    5              25               9                        2.08          468
 Veterinary     animal
 Medicine       nutrition,
                supplements,
                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.


    Dated: February 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4655 Filed 3-2-04; 8:45 am]
BILLING CODE 4160-01-S