[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18678-18679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07572]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2865]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
Quantitative Testing for the Development of Food and Drug
Administration Communications
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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by June 2, 2025.
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 0910-0865. 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,
PRAStaff@fda.hhs.gov.
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 Quantitative Testing for the Development of FDA
Communications
OMB Control Number 0910-0865--Extension
This notice requests extension of OMB approval of the FDA
information collection for a generic clearance that allows FDA to use
quantitative social/behavioral science data collection techniques
(i.e., surveys and experimental studies) to test consumers' reactions
to FDA communications or educational messaging about FDA-regulated food
and cosmetic products, dietary supplements, and animal food and feed.
To ensure that communications activities and educational campaigns have
the highest potential to be received, understood, and accepted by those
for whom they are intended, it is important to assess communications
while they are under development. Understanding consumers' attitudes,
motivations, and behaviors in response to potential communications and
education messaging plays an important role in improving FDA's
communications.
If the following conditions are not met, FDA will submit an
information collection request to OMB for approval through the normal
PRA process:
The collections are voluntary;
The collections are low burden for participants (based on
considerations of total burden hours, total number of participants, or
burden hours per participant) and are low cost for both the
participants and the Federal Government;
The collections are noncontroversial;
Personally identifiable information (PII) is collected
only to the extent necessary \1\ and is not retained;
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\1\ For example, collections that collect PII to provide
remuneration for participants of focus groups and cognitive
laboratory studies will be submitted under this request. All Privacy
Act requirements will be met.
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Information gathered will not be used for the purpose of
substantially informing influential policy decisions; \2\ and
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\2\ As defined in OMB and Agency Information Quality Guidelines,
``influential'' means that ``an agency can reasonably determine that
dissemination of the information will have or does have a clear and
substantial impact on important public policies or important private
sector decisions.''
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[[Page 18679]]
The collections will not be designed or expected to yield
statistical data or used as though the results are generalizable to the
population of study.
To obtain approval for an individual generic collection submission
that meets the conditions of this generic clearance, an abbreviated
supporting statement will be submitted to OMB along with supporting
documentation (e.g., a copy of the survey or experimental design and
stimuli for testing).
FDA will submit individual quantitative collections under this
generic clearance to OMB. Individual quantitative collections will also
undergo review by FDA's Human Subject Protection Program, senior
leadership in the Center for Food Safety and Applied Nutrition, and PRA
specialists.
Respondents to this collection of information may include a wide
range of consumers and other FDA stakeholders such as producers and
manufacturers who are regulated under FDA-regulated food and cosmetic
products, dietary supplements, and animal food and feed.
In the Federal Register of July 31, 2024 (89 FR 61453), 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\
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Number of Total
Activity Number of responses per annual Average burden per Total
respondents respondent responses response hours
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Cognitive Interviews Screener 720 1 720 0.083 (5 minutes).......... 60
Cognitive Interviews......... 144 1 144 1.......................... 144
Pre-test Study Screener...... 2,400 1 2,400 0.083 (5 minutes).......... 199
Pre-testing Study............ 480 1 480 0.25 (15 minutes).......... 120
Self-Administered Surveys/ 75,000 1 75,000 0.083 (5 minutes).......... 6,225
Experimental Studies
Screener.
Self-Administered Surveys/ 15,000 1 15,000 0.25 (15 minutes).......... 3,750
Experimental Studies.
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Total.................... ............ .............. .......... ........................... 10,498
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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. Current estimates are based on both historical numbers of
participants from past projects as well as estimates for projects to be
conducted in the next 3 years. The number of participants to be
included in each new survey will vary, depending on the nature of the
compliance efforts and the target audience.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07572 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P