[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22906-22908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
    <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 https://www.regulations.gov 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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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
                                             -----------------------------------------------------------------------------------------------------------
    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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