[Federal Register Volume 85, Number 27 (Monday, February 10, 2020)]
[Notices]
[Pages 7564-7565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 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 and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the creation of a new collection of information 
entitled ``Generic Clearance for Qualitative Data to Support Social and 
Behavioral Research for Food, Dietary Supplements, Cosmetics, and 
Animal Food and Feed.''

DATES: Submit either electronic or written comments on the collection 
of information by April 10, 2020.

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 April 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 10, 2020. 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:
     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-2019-N-5841 for ``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.'' 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.
     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.

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: 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

[[Page 7565]]

Agencies to provide a 60-day notice in the Federal Register concerning 
each proposed 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-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 (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 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.
    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 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.           7,200               1           7,200  .08 (5 minutes).........................             576
Focus Group/Small Group Discussion............           2,400               1           2,400  1.5.....................................           3,600
Observation Screening.........................             720               1             720  .08 (5 minutes).........................              58
Observations..................................             144               1             144  2.......................................             288
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    Total.....................................          15,664  ..............  ..............  ........................................           5,306
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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 5,306 hours and 15,664 
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.

    Dated: January 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02527 Filed 2-7-20; 8:45 am]
BILLING CODE 4164-01-P