Document ID: FDA-2013-N-0748-0002
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2013-12-02T05:00Z

[Federal Register Volume 78, Number 231 (Monday, December 2, 2013)]
[Notices]
[Pages 72092-72093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28736]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0748]

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 January 
2, 2014.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0677. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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 0910-0677)--Extension

    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:
     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.
    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.
    In the Federal Register of June 28, 2013 (78 FR 38993), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this information collection as follows:

[[Page 72093]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Focus Groups About Drug Products...................................           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.

    Dated: November 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28736 Filed 11-29-13; 8:45 am]
BILLING CODE 4160-01-P