Document ID: FDA-2018-N-3037-0006
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2022-01-28T05:00Z

[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4625-4626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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: 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, 
[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 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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     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