82 FR 43243 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 177 (September 14, 2017)

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.

[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43243-43244]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0594]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Focus Groups as Used 
by the Food and Drug Administration (All Food and Drug Administration-
Regulated Products)

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 October 
16, 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 0910-0497. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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 as Used by the Food and Drug 
Administration (All FDA-Regulated Products), OMB Control Number 0910-
0497.
    FDA conducts voluntary focus group interviews on a variety of 
topics involving FDA-regulated products, including drugs, biologics, 
devices, food, tobacco, and veterinary medicine.
    Focus groups provide an important role in gathering information 
because they allow for a more in-depth understanding of patients' and 
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 patient and consumer information that is useful 
for developing variables and measures for quantitative studies,
     To better understand patients' and 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.
    In the Federal Register of April 21, 2017 (82 FR 18763), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 43244]]

information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                           Annual
                              Activity                                  Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
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Focus Group Interviews.............................................           8,800                1            8,800             1.75           15,400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19492 Filed 9-13-17; 8:45 am]
 BILLING CODE 4164-01-P