[Federal Register Volume 72, Number 58 (Tuesday, March 27, 2007)]
[Notices]
[Pages 14279-14280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5505]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0098]


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.

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

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.

DATES: Submit written or electronic comments on the collection of 
information by May 29, 2007.

ADDRESSES:  Submit electronic comments on the collection of information 
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: Jonna Capezzuto, Office of the Chief 
Information Officer (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 FDA (OMB Control Number 0910-0497)--Extension

    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 do quantitative 
studies. Focus groups serve the narrowly defined need for direct and 
informal opinion on a specific topic and as a qualitative research tool 
have three major purposes:
     To obtain consumer information that is useful for 
developing variables and measures for quantitative studies,
     To better understand consumers' attitudes and emotions in 
response to topics and concepts, and
     To further explore findings obtained from quantitative 
studies.
    FDA will use focus group findings to test and refine their ideas, 
but will generally conduct further research before making important 
decisions such as adopting new policies and allocating or redirecting 
significant resources to support these policies.
    FDA estimates the burden for completing the forms for this 
collection of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                       No. of      No. of Focus                    Hours of Duration
                                        Focus     Groups Sessions     No. of        for Each Group       Total
   FDA Center          Subject       Groups per      Conducted     Participants        (Includes         Hours
                                        Study        Annually        per Group        Screening)
----------------------------------------------------------------------------------------------------------------
Center for        May use focus               1                 5             9                  1.58         71
 Biologics         groups when
 Evaluation and    appropriate
 Research
----------------------------------------------------------------------------------------------------------------

[[Page 14280]]

 
Center for Drug   Varies (e.g.,              10               200             9                  1.58      2,844
 Evaluation and    direct-to-
 Research          consumer Rx drug
                   promotion,
                   physician
                   labeling of Rx
                   drugs,
                   medication
                   guides, over-the-
                   counter drug
                   labeling, risk
                   communication)
----------------------------------------------------------------------------------------------------------------
Center for        Varies (e.g., FDA           4                16             9                  2.08        300
 Devices and       Seal of
 Radiological      Approval,
 Health            patient
                   labeling,
                   tampons, online
                   sales of medical
                   products, latex
                   gloves)
----------------------------------------------------------------------------------------------------------------
Center for Food   Varies (e.g.,               8                40             9                  1.58        569
 Safety and        food safety,
 Applied           nutrition,
 Nutrition         dietary
                   supplements, and
                   consumer
                   education)
----------------------------------------------------------------------------------------------------------------
Center for        Varies (e.g.,               5                25             9                  2.08        468
 Veterinary        animal
 Medicine          nutrition,
                   supplements,
                   labeling of
                   animal Rx)
----------------------------------------------------------------------------------------------------------------
Total             .................          28               286             9                  1.78      4,252
----------------------------------------------------------------------------------------------------------------
\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: March 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5505 Filed 3-26-07; 8:45 am]
BILLING CODE 4160-01-S