Notice2022-08189
Agency Information Collection Activities; Proposed Collection; 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
April 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, we, or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection entitled "Generic Clearance for Quick Turnaround Testing of Communication Effectiveness."
Full Text
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<title>Federal Register, Volume 87 Issue 74 (Monday, April 18, 2022)</title>
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[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22906-22908]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08189]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0430]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for Quick Turnaround Testing of
Communication Effectiveness
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing an opportunity for public comment on the proposed collection
of certain information by the agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and
[[Page 22907]]
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection entitled
``Generic Clearance for Quick Turnaround Testing of Communication
Effectiveness.''
DATES: Submit either electronic or written comments on the collection
of information by June 17, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 17, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 17, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-0430 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic Clearance for Quick
Turnaround Testing of Communication Effectiveness.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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#c696948795b2a7a0a086a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="0d5d5f4c5e796c6b6b4d6b696c2365657e236a627b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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,
[[Page 22908]]
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 which 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 in-depth 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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Survey type Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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In-depth Interviews, Cognitive Interviews 45 1 45 0.083 (5 minutes)......................... 4
Screener.
In-depth Interviews, Cognitive Interviews... 9 1 9 1......................................... 9
In-depth Interviews Screener................ 900 1 900 0.083 (5 minutes)......................... 75
In-depth 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
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Total................................... .............. .............. .............. .......................................... 10,881
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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: April 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08189 Filed 4-15-22; 8:45 am]
BILLING CODE 4164-01-P
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