[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Notices]
[Pages 21193-21195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07441]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1157]


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) 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 
which allows the submission of individual generic requests for 
obtaining qualitative data to support social and behavioral research 
for food, dietary supplements, cosmetics, and animal food and feed.

DATES: Either electronic or written comments on the collection of 
information must be submitted by June 9, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 9, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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-2023-N-1157 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Generic

[[Page 21194]]

Clearance for Qualitative Data To Support Social and Behavioral 
Research for Food, Dietary Supplements, Cosmetics, and Animal Food and 
Feed.'' 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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 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 Qualitative Data To Support Social and Behavioral 
Research for Food, Dietary Supplements, Cosmetics, and Animal Food and 
Feed

OMB Control Number 0910-0891--Extension

    The Office of Management and Budget's (OMB) Office of Information 
and Regulatory Affairs (OIRA) has issued memoranda that provides an 
overview of administrative flexibilities available to assist agencies 
in complying with their statutory obligations under the PRA. Among 
these flexibilities is use of a generic clearance for certain 
information collection activities. A generic clearance may be 
appropriate when (1) the need for the data collection can be evaluated 
in advance, as part of the review of the proposed plan, but (2) the 
Agency cannot determine the details of the specific individual 
collections until a later time. Generic clearances cover collections 
that are voluntary, low-burden, and uncontroversial.
    This generic clearance supports research intended to help CFSAN 
understand stakeholders' perceptions, attitudes, motivations, and 
behaviors. Understanding these perceptions, attitudes, motivations, and 
behaviors plays an important role in improving FDA's communications 
which impact these various stakeholders and assists in the development 
of quantitative study proposals to complement other important research 
efforts in the Agency.
    To ensure that communications activities have the highest effect, 
we will conduct research and studies relating to the control and 
prevention of disease and the safety and health of the public. FDA is 
requesting OMB approval for the use of this generic collection of 
information that allows FDA to use qualitative social/behavioral 
science data collection techniques (i.e., individual in-depth 
interviews (IDIs), small group discussions, focus groups, and 
observations) to better understand stakeholders' perceptions, 
attitudes, motivations, and behaviors regarding various issues 
associated with food and cosmetic products, dietary supplements, and 
animal food and feed. Understanding these consumers', manufacturers', 
and producers' perceptions, attitudes, motivations, and behaviors plays 
an important role in improving FDA's communications that impact these 
various stakeholders and in assisting in the development of 
quantitative study proposals, complementing other important research 
efforts in the Agency.
    To obtain approval for an individual generic submission 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).
    Selection for potential respondents is done via a screening process 
to match the best possible respondent to each individual generic 
submission. Respondents to individual requests made under the generic 
clearance, once approved by OMB, 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. Participation is voluntary.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 21195]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
              Type of interview                   Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
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Individual In-Depth Interview Screening......           4,800               1           4,800  .08 (5 minutes)..........................             384
Individual In-Depth Interviews...............             400               1             400  1........................................             400
Focus Group/Small Group Participant Screening          10,800               1          10,800  .08 (5 minutes)..........................             864
Focus Groups/Small Group Discussion..........           3,600               1           3,600  1.5......................................           5,400
Observation Screening........................             720               1             720  .08 (5 minutes)..........................              58
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.

    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 collections we have conducted under 
this generic collection of information have informed and helped us 
better understand stakeholder perceptions, attitudes, motivations, and 
behaviors to help us improve our communications to them.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: April 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07441 Filed 4-7-23; 8:45 am]
BILLING CODE 4164-01-P