Document ID: FDA-2019-N-0430-0008
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
Posted Date: 2022-08-24T04:00Z

[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51995-51996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18265]

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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.

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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 September 23, 2022.

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 0910-0876. 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, 
[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.

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\
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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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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
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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: 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