83 FR 44888 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of FDA Communications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 171 (September 4, 2018)

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 Quantitative Testing for the Development of FDA Communications.''

[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44888-44890]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3037]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Generic Clearance for Quantitative Testing for the 
Development of FDA Communications

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 Quantitative Testing for the 
Development of FDA Communications.''

DATES: Submit either electronic or written comments on the collection 
of information by November 5, 2018.

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 November 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 5, 2018. 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

[[Page 44889]]

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-2018-N-3037 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Generic Clearance for 
Quantitative Testing for the Development of FDA Communications.'' 
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.thefederalregister.org/fdsys/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. 3501-3520), 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 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 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.
    FDA estimates the burden of this collection of information as 
follows:

              Table 1--Estimated Annual Reporting Burden by Anticipated Data Collection Methods \1\
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                                                                     Number of
                   Survey type                       Number of     responses per   Total annual     Total hours
                                                    respondents     respondent       responses
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Cognitive Interviews Screener...................             720               1             720              60
Cognitive Interviews............................             144               1             144             144
Pre-test Study Screener.........................           2,400               1           2,400             199
Pre-testing Study...............................             480               1             480             120
Self-administered Surveys/Experimental Studies            75,000               1          75,000           6,225
 Screener.......................................
Self-Administered Surveys/Experimental Studies..          15,000               1          15,000           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: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19088 Filed 8-31-18; 8:45 am]
 BILLING CODE 4164-01-P