Document ID: FDA-2019-N-5841-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Generic Clearance
for Qualitative Data To Support Social and Behavioral Research for Food,
Dietary Supplements, Cosmetics, and Animal Food and Feed
Posted Date: 2020-07-06T04:00Z

[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Pages 40299-40300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14365]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5841]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Generic Clearance for 
Qualitative Data To Support Social and Behavioral Research for Food, 
Dietary Supplements, Cosmetics, and Animal Food and Feed

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 August 5, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted 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 title of this 
information collection is ``Generic Clearance for Qualitative Data to 
Support Social and Behavioral Research for Food, Dietary Supplements, 
Cosmetics, and Animal Food and Feed.'' 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 Qualitative Data to Support Social and Behavioral 
Research for Food, Dietary Supplements, Cosmetics, and Animal Food and 
Feed

OMB Control Number 0910-NEW

    This notice announces the FDA information collection request from 
the OMB for a generic clearance that will allow FDA to use qualitative 
social/behavioral science data collection techniques (i.e., individual 
in-depth interviews, small group discussions, focus groups, and 
observations) to understand stakeholders' perceptions, attitudes, 
motivations, and behaviors better regarding various issues associated 
with food and cosmetic products, dietary supplements, and animal food 
and feed. Understanding consumers', manufacturers', and producers' 
perceptions, attitudes, motivations, and behaviors plays an important 
role in improving FDA's communications impacting these various 
stakeholders and in assisting in the development of quantitative study 
proposals, complementing other important research efforts in the 
Agency.
    FDA will only submit a collection for approval under this generic 
clearance if it meets the following conditions:
     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 information; 
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.
    If these conditions are not met, FDA will submit an information 
collection request to OMB for approval through the normal PRA process.
    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 interview or moderator guide, screening questionnaire).
    FDA will submit individual qualitative collections under this 
generic clearance to the OMB. Individual qualitative collections will 
also undergo review by FDA's institutional review board, senior 
leadership in the Center for Food Safety and Applied Nutrition, and PRA 
specialists.
    Description of Participants: Participants in 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 February 10, 2020 (85 FR 7564), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although five comments

[[Page 40300]]

were received, they were not responsive to the four collection of 
information topics solicited and therefore will not be discussed in 
this document.
    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
      Type of interview           Number of     responses per    Total annual     Average burden    Total hours
                                 respondents     respondent        responses       per response
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Individual In-Depth Interview           4,800               1  4,800...........  0.08 (5                     384
 Screening.                                                                       minutes).
Individual In-Depth                       400               1  400.............  1..............             400
 Interviews.
Focus Group/Small Group                10,800               1  10,800..........  0.08 (5                     864
 Participant Screening.                                                           minutes).
Focus Group/Small Group                 3,600               1  3,600...........  1.5............           5,400
 Discussion.
Observation Screening........             720               1  720.............  0.08 (5                      58
                                                                                  minutes).
Observations.................             144               1  144.............  2..............             288
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    Total....................          20,464  ..............  ................  ...............           7,394
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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 7,394 hours and 20,464 
responses. 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 collection will vary, depending on the nature of 
the compliance efforts and the target audience.
    The estimated burden hours for focus groups for this collection of 
information have been increased from the burden published in the 
Federal Register on February 10, 2020, to the burden published in this 
Federal Register notice. The adjustment in burden hours for focus 
groups reflects the increased need for this type of data collection 
across the above-mentioned topic areas.

    Dated: June 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14365 Filed 7-2-20; 8:45 am]
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