[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Notices]
[Pages 18556-18557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06434]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0796]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Testing 
Communications by the Food and Drug Administration's Center for Devices 
and Radiological Health

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: Submit written comments (including recommendations) on the 
collection of information by April 27, 2023.

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 0910-0678. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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.

Testing Communications by FDA's Center for Devices and Radiological 
Health

OMB Control Number 0910-0678--Extension

    FDA is authorized by section 1003(d)(2)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational 
and public information programs. FDA must conduct needed research to 
ensure that such programs have the highest likelihood of being 
effective. Improving communications by FDA's Center for Devices and 
Radiological Health (CDRH) involves many research methods, including 
individual indepth interviews, mall-intercept interviews, focus groups, 
self-administered surveys, gatekeeper reviews, and omnibus telephone 
surveys.
    The information collected will serve three major purposes. First, 
as formative research it will provide critical knowledge needed about 
target audiences to develop messages and campaigns about product use. 
Knowledge of consumer, caregiver, and healthcare professional decision-
making processes will provide a better understanding of target 
audiences that FDA needs to design effective communication strategies, 
messages, and labels.
    Second, as initial testing, the collected information will allow 
FDA to assess the potential effectiveness of messages and materials in 
reaching and successfully communicating with intended audiences. 
Testing messages with a sample of the target audience will allow FDA to 
refine messages while still in the developmental stage. Respondents 
will be asked to give their reaction to the messages in either 
individual or group settings.
    Third, as evaluative research, the collected information will allow 
FDA to ascertain the effectiveness of the messages and the distribution 
method in achieving the objectives of the message campaign. Evaluation 
of message campaigns is a vital link in continuous improvement of 
communications at FDA.
    FDA expects to conduct studies under this generic information 
collection using

[[Page 18557]]

a variety of research methods. We estimate that the burden to 
respondents will average 16 minutes each (varying from 5 minutes to 90 
minutes). FDA estimates the burden of this collection of information 
based on prior experience with the various types of data collection 
methods described earlier.
    In the Federal Register of November 2, 2022 (87 FR 66192), 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 collection of information as 
follows:

                                                   Table 1--Estimated Annual Reporting Burden \1\ \2\
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                                                                 Number of
          Type of respondent/survey              Number of     responses per   Total annual          Average burden  per response           Total hours
                                                respondents     respondent       responses
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                                                                     General Public
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Individual indepth interviews...............             420               1             420  0.75 (45 minutes).........................             315
General public focus group interviews.......             288               1             288  1.50 (1 hour, 30 minutes).................             432
Intercept interviews: central location......             200               1             200  0.25 (15 minutes).........................              50
Intercept interviews: telephone.............           4,000               1           4,000  0.08 (5 minutes)..........................             320
Self-administered surveys...................           2,400               1           2,400  0.25 (15 minutes).........................             600
Gatekeeper reviews..........................             400               1             400  0.50 (30 minutes).........................             200
Omnibus surveys.............................           1,200               1           1,200  0.17 (10 minutes).........................             204
                                             -----------------------------------------------------------------------------------------------------------
    Total (general public)..................  ..............  ..............  ..............  ..........................................           2,121
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                                                                 Healthcare Professional
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Healthcare professional individual indepth                72               1              72  0.75 (45 minutes).........................              54
 interviews.
Healthcare professional focus group                      144               1             144  1.50 (1 hour, 30 minutes).................             216
 interviews.
                                             -----------------------------------------------------------------------------------------------------------
    Total (healthcare professional).........  ..............  ..............  ..............  ..........................................             270
    Total (overall).........................  ..............  ..............  ..............  ..........................................           2,391
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    Over the next 3-year approval period, we anticipate increasing our 
capability to conduct more communication surveys, which aligns with 
CDRH's strategic priorities. We have adjusted our burden estimates 
accordingly. Additionally, we have added an estimated hour burden for 
``healthcare professional individual indepth interviews.'' These 
changes reflect an overall increase of 315 burden hours and a 
corresponding increase of 276 responses annually.

    Dated: March 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06434 Filed 3-28-23; 8:45 am]
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