
[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67300-67301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-28252]



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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) 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: Fax written comments on the collection of information by January 
28, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Generic Clearance for Quantitative Testing for the Development 
of FDA Communications.'' 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, 
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--NEW
    This notice announces the FDA information collection request from 
OMB for a generic clearance that will allow 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.
    To obtain approval for a collection 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 4, 2018 (83 FR 44888), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden, by Anticipated Data Collection Methods
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                                                                                       Number of
                            Survey type                                Number of     responses per   Total annual    Average burden per     Total hours
                                                                      respondents     respondent       responses          response
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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      .25 (15 minutes)             120
Self-administered surveys/experimental Studies Screener...........          75,000               1          75,000     0.083 (5 minutes)           6,225
Self-Administered Surveys/Experimental Studies....................          15,000               1          15,000      .25 (15 minutes)           3,750

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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.

    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: December 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-28252 Filed 12-27-18; 8:45 am]
 BILLING CODE 4164-01-P


