[Federal Register: November 25, 2005 (Volume 70, Number 226)]
[Page 71165-71167]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0443]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Focus Groups as Used by the Food and Drug 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 24, 2006.

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

[[Page 71166]]

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 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 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 as follows:
    The total annual estimated burden imposed by this collection of 
information is 4,252 hours annually.

                                                   Table 1.\1\
                                                     No. of Focus                      Hours of
                                     No. of Focus       Groups          No. of       Duration for
 Center            Subject            Groups per       Sessions      Participants     Each Group     Total Hours
                                         Study         Conducted       per Group       (Includes
                                                       Annually                       Screening)
Center       May Use Focus Groups             1               5               9               1.58         71
 for             When Appropriate
 ion and
Center    Varies (e.g., Direct-to-           10             200               9               1.58      2,844
 for                             Consumer Rx Drug
 Drug        Promotion, Physician
 Evaluat    Labeling of Rx Drugs,
 ion and  Medication Guides, Over-
 Researc                     the-Counter Drug
 h                 Labeling, Risk
Center     Varies (e.g., FDA Seal             4              16               9               2.08        300
 for         of Approval, Patient
 Devices   Labeling, Tampons, On-
 and        line Sales of Medical
 Radiolo   Products, Latex Gloves
Center         Varies (e.g., Food             8              40               9               1.58        569
 for           Safety, Nutrition,
 Food        Dietary Supplements,
 Safety                          Consumer Education)
Center       Varies (e.g., Animal             5              25               9               2.08        468
 for      Nutrition, Supplements,
 Veterin   Labeling of Animal Rx)
Total     ........................           28             286     ..............            1.78      4,252
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 71167]]

    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, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23248 Filed 11-23-05; 8:45 am]