Document ID: FDA-2010-N-0122-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Focus Groups About Drug Products, as Used by the Food and Drug Administration
Posted Date: 2010-03-22T04:00Z

[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Notices]               
[Page 13548-13549]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr10-63]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0122]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Focus Groups About Drug Products, 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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on focus groups about drug products used by 
FDA to gauge informally public opinion, on a variety of subjects 
related to consumer, patient, or healthcare professional perceptions 
and use of drug products and related materials, including but not 
limited to, direct-to-consumer (DTC) prescription drug promotion, 
physician labeling of prescription drugs, Medication Guides, over-the-
counter (OTC) drug labeling, emerging risk communications, patient 
labeling, online sales of medical products, and consumer and 
professional education.

DATES:  Submit written or electronic comments on the collection of 
information by May 21, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

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

[[Page 13549]]

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 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 About Drug Products, as Used by the Food and Drug 
Administration

    Focus groups provide an important role in gathering information 
because they allow for a more in-depth understanding of individuals' 
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 information that is useful for developing 
variables and measures for quantitative studies,
     To better understand people's 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 its ideas and 
to help develop messages and other communications, 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's Center for Drug Evaluation and Research, Office of the 
Commissioner, and any other centers or offices conducting focus groups 
about regulated drug products may need to conduct focus groups on a 
variety of subjects related to consumer, patient, or healthcare 
professional perceptions and use of drug products and related 
materials, including but not limited to, DTC prescription drug 
promotion, physician labeling of prescription drugs, Medication Guides, 
OTC drug labeling, emerging risk communications, patient labeling, 
online sales of medical products, and consumer and professional 
education.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                           No. of Responses  Total Annual  Responses      Hours per
   No. of  Respondents      per Respondent           (Hours)               Response            Total Hours
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1,440                                     1                    1,440               1.75                    2,520
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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 20 focus group studies using 160 focus 
groups with an average of 9 persons per group, and lasting an average 
of 1.75 hours each. FDA is requesting this burden for unplanned focus 
groups so as not to restrict the agency's ability to gather information 
on public sentiment for its proposals in its regulatory and 
communications programs.

    Dated: March 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6172 Filed 3-19-10; 8:45 am]
BILLING CODE 4160-01-S