Notice2022-18265
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
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
August 24, 2022
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
<html>
<head>
<title>Federal Register, Volume 87 Issue 163 (Wednesday, August 24, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51995-51996]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18265]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0430]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
Quick Turnaround Testing of Communication Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 September 23, 2022.
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 0910-0876. 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,
<a href="/cdn-cgi/l/email-protection#124240534166737474527476733c7a7a613c757d64"><span class="__cf_email__" data-cfemail="80d0d2c1d3f4e1e6e6c0e6e4e1aee8e8f3aee7eff6">[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.
Generic Clearance for Quick Turnaround Testing of Communication
Effectiveness
OMB Control Number 0910-0876--Extension
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It enables FDA to focus more on
preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role consumers and stakeholders play in ensuring the safety of the food
supply, which helps ensure that suppliers produce food that meets U.S.
safety standards.
Occasionally, FDA will need to communicate with consumers and other
stakeholders about immediate health issues that could affect public
health and safety. This collection of information allows the use of
fast-track methods of communication such as quick turnaround surveys,
focus groups, and indepth interviews collected from consumers and other
stakeholders to communicate FDA issues of immediate and important
public health significance. We plan on using these methods of
communication to collect vital public health and safety information.
For example, these methods of communication might be used when
there is a foodborne illness outbreak, food recall, or other situation
requiring expedited FDA food, dietary supplement, cosmetics, or animal
food or feed communications. So that FDA may better protect the public
health, the Agency needs quick turnaround information provided by this
collection of information to help ensure its messaging has reached the
target audience, has been effective, and, if needed, to update its
communications during these events.
Respondents to this collection of information include a wide range
of consumers and other FDA stakeholders such as producers and
manufacturers of FDA-regulated food and cosmetic products, dietary
supplements, and animal food and feed. Participation will be voluntary.
In the Federal Register of April 18, 2022 (87 FR 22906), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although three comments were received, they
were not responsive to the four collection of information topics
solicited.
We estimate the burden of this collection of information as
follows:
[[Page 51996]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Survey type Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indepth Interviews, Cognitive Interviews 45 1 45 0.083 (5 minutes)......................... 4
Screener.
Indepth Interviews, Cognitive Interviews.... 9 1 9 1......................................... 9
Indepth Interviews Screener................. 900 1 900 0.083 (5 minutes)......................... 75
Indepth Interviews.......................... 180 1 180 1......................................... 180
Survey Cognitive Interviews Screener........ 45 1 45 0.083 (5 minutes)......................... 4
Survey Cognitive Interviews................. 9 1 9 1......................................... 9
Pretest Survey Screener..................... 750 1 750 0.083 (5 minutes)......................... 62
Pretest Survey.............................. 150 1 150 0.25 (15 minutes)......................... 38
Self-Administered Surveys--Study Screener... 75,000 1 75,000 0.083 (5 minutes)......................... 6,225
Self-Administered Surveys................... 15,000 1 15,000 0.25 (15 minutes)......................... 3,750
Focus Group/Small Group, Cognitive Groups 180 1 180 0.083 (5 minutes)......................... 15
Screener.
Focus Group/Small Group, Cognitive Groups... 60 1 60 1.5 (90 minutes).......................... 90
Focus Group/Small Group Participant 720 1 720 0.083 (5 minutes)......................... 60
Screening.
Focus Group/Small Group Discussion.......... 240 1 240 1.5 (90 minutes).......................... 360
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 10,881
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: August 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18265 Filed 8-23-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 24, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.