Document ID: FDA-2010-N-0122-0002
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: 2010-07-09T04:00Z

[Federal Register: July 9, 2010 (Volume 75, Number 131)]
[Notices]               
[Page 39541]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy10-46]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 August 
9, 2010.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-new and 
title Focus Groups About Drug Products, as Used by the Food and Drug 
Administration. Also include the FDA 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: 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 About Drug Products, As Used By the Food and Drug 
Administration--(OMB Control Number 0910-New)

    Focus groups provide an important role in gathering information 
because they allow for a more indepth 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, direct-to-consumer 
prescription drug promotion, physician labeling of prescription drugs, 
Medication Guides, over-the-counter drug labeling, emerging risk 
communications, patient labeling, online sales of medical products, and 
consumer and professional education.
    In the Federal Register of March 22, 2010, (75 FR 13548), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                 Number of Responses      Total Annual          Hours per
      No. of  Respondents          per Respondent       Responses (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: July 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16769 Filed 7-8-10; 8:45 am]
BILLING CODE 4160-01-S