Notice2022-01730
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
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
January 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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).
Full Text
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<title>Federal Register, Volume 87 Issue 19 (Friday, January 28, 2022)</title>
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[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4625-4626]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01730]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3037]
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, Agency, or we) 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 February 28, 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 0910-0865. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
<a href="/cdn-cgi/l/email-protection#623230233116030404220406034c0a0a114c050d14"><span class="__cf_email__" data-cfemail="530301120027323535133537327d3b3b207d343c25">[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 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:
<bullet> The collections are voluntary;
<bullet> 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;
<bullet> The collections are noncontroversial;
<bullet> 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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<bullet> 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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<bullet> Information gathered will yield qualitative findings; 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.
[[Page 4626]]
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 Research Involving Human Subjects Committee,
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 September 9, 2021 (86 FR 50544), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and, therefore, will not be discussed in this document.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden by Anticipated Data Collection Methods \1\
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Number of
Survey type Number of disclosures Total annual Average burden per response Total hours
respondents per respondent disclosures
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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-test Study............................... 480 1 480 0.25 (15 minutes)........................ 120
Self-administered Surveys/Experimental 75,000 1 75,000 0.083 (5 minutes)........................ 6,225
Studies Screener.
Self-administered Surveys/Experimental 15,000 1 15,000 0.25 (15 minutes)........................ 3,750
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. The total estimated annual burden is 10,498 hours. 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: January 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01730 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P
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