Notice2023-06434
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 29, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 60 (Wednesday, March 29, 2023)</title>
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[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Notices]
[Pages 18556-18557]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#db8b899a88afbabdbd9bbdbfbaf5b3b3a8f5bcb4ad"><span class="__cf_email__" data-cfemail="b5e5e7f4e6c1d4d3d3f5d3d1d49bddddc69bd2dac3">[email protected]</span></a>.
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
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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.
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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]
BILLING CODE 4164-01-P
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