[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Page 13816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05099]



[[Page 13816]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3586]


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 or we) 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 (the PRA).

DATES: Fax written comments on the collection of information by April 
14, 2017.

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 [email protected]. 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, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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 November 7, 2016 (81 FR 78161), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received 
in response to the notice.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                  Information collection 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: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05099 Filed 3-14-17; 8:45 am]
 BILLING CODE 4164-01-P