Notice2021-19480
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications
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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
September 9, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA 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 collection of information entitled "Generic Clearance for Quantitative Testing for the Development of FDA Communications," which collects individual generic quantitative information (e.g., surveys, experimental studies) to test communications or educational messages on FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed while they are being developed or are in review.
Full Text
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<title>Federal Register, Volume 86 Issue 172 (Thursday, September 9, 2021)</title>
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[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50544-50545]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19480]
[[Page 50544]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3037]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for Quantitative Testing for the
Development of Food and Drug Administration Communications
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA 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 collection of information entitled
``Generic Clearance for Quantitative Testing for the Development of FDA
Communications,'' which collects individual generic quantitative
information (e.g., surveys, experimental studies) to test
communications or educational messages on FDA-regulated food and
cosmetic products, dietary supplements, and animal food and feed while
they are being developed or are in review.
DATES: Submit either electronic or written comments on the collection
of information by November 8, 2021.
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 November 8, 2021. 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 November 8, 2021. 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-2018-N-3037 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic Clearance for
Quantitative Testing for the Development of FDA Communications.''
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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#d181839082a5b0b7b791b7b5b0ffb9b9a2ffb6bea7"><span class="__cf_email__" data-cfemail="07575546547366616147616366296f6f7429606871">[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
[[Page 50545]]
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 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.
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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden by Anticipated Data Collection Methods \1\
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Number of
Number of disclosures Total annual Average burden
Survey type respondents per disclosures per response Total hours
respondent
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Cognitive Interviews Screener. 720 1 720 0.083 (5 60
minutes).
Cognitive Interviews.......... 144 1 144 1............... 144
Pre-test Study Screener....... 2,400 1 2,400 0.083 (5 199
minutes).
Pre-test Study................ 480 1 480 0.25 (15 120
minutes).
Self-administered Surveys/ 75,000 1 75,000 0.083 (5 6,225
Experimental Studies Screener. minutes).
Self-administered Surveys/ 15,000 1 15,000 0.25 (15 3,750
Experimental Studies. minutes).
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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: September 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19480 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P
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