[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Notices]
[Pages 5219-5220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0345]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Data To Support Drug 
Product Communications 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.

DATES: Submit written comments (including recommendations) on the 
collection of information by February 18, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0695. 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.

Data to Support Drug Product Communications as Used by the Food and 
Drug Administration

OMB Control Number 0910-0695--Extension

    This information collection supports Agency outreach efforts. 
Testing of communication messages in advance of a communication 
campaign provides an important role in improving FDA communications as 
they allow for an indepth understanding of individuals' attitudes, 
beliefs, motivations, and feelings. The methods to be employed include 
individual indepth interviews, general public focus group interviews, 
intercept interviews, self-administered surveys, gatekeeper surveys, 
and professional clinician focus group interviews, all on a voluntary 
basis.
    The methods to be used serve the narrowly defined need for direct 
and informal opinion on a specific topic and, as a qualitative research 
tool, have two major purposes: (1) To obtain information that is useful 
for developing variables and measures for formulating the basic 
objectives of risk

[[Page 5220]]

communication campaigns and (2) to assess the potential effectiveness 
of messages and materials in reaching and successfully communicating 
with their intended audiences. We will use these methods to test and 
refine our 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. We will use this 
mechanism to test messages about regulated drug products on a variety 
of subjects related to consumer, patient, or healthcare professional 
perceptions and about 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 sale of medical products, and consumer and 
professional education.
    Annually, we project about 45 communication studies using the 
variety of test methods listed in this document. We are requesting an 
extension of these burden hours so as not to restrict our ability to 
gather information on public sentiment for FDA's proposals in its 
regulatory and communications programs.
    In the Federal Register of June 17, 2020 (85 FR 36591), we 
published a 60-day notice requesting public comment on the proposed 
collection of 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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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Interviews/Surveys............          43,875               1          43,875  0.21925 (12                9,620
                                                                                 minutes).
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\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: January 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-01030 Filed 1-15-21; 8:45 am]
BILLING CODE 4164-01-P


