Document ID: FDA-2016-N-3586-0005
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: 2019-12-31T05:00Z

[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72369-72370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28247]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) 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 (PRA).

DATES: Fax written comments on the collection of information by January 
30, 2020.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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 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.
    We use information gathered from focus group findings to test and 
refine 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.
    Our Center for Drug Evaluation and Research, as well as other 
Agency components, engage focus groups about

[[Page 72370]]

regulated drug products on a variety of topics related to consumer, 
patient, or healthcare professional perceptions and use of drug 
products and related materials. These materials may include, but are 
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 July 17, 2019 (84 FR 34186), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    Annually, we project that 20 studies will be initiated using 160 
focus groups with an average of 9 persons per group. We assume each 
focus group will last an average of 1.75 hours.
    We estimate the burden for the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Study..................................................           1,440                1            1,440             1.75            2,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: December 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28247 Filed 12-30-19; 8:45 am]
 BILLING CODE 4164-01-P