[Federal Register Volume 87, Number 211 (Wednesday, November 2, 2022)]
[Notices]
[Pages 66192-66194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0796]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Testing Communications by the Food and Drug 
Administration's Center for Devices and Radiological Health

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 studies regarding 
communications by FDA's Center for Devices and Radiological Health 
(CDRH). This information will be used to explore concepts of interest 
and assist in the development and modification of communication 
messages and campaigns to fulfill the Agency's mission to protect the 
public health.

DATES: Either electronic or written comments on the collection of 
information must be submitted by January 3, 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 January 3, 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:

[[Page 66193]]

     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-2013-N-0796 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Testing Communications Regarding 
Products Regulated by FDA's Center for Devices and Radiological 
Health.'' 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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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.

Testing Communications by FDA's Center for Devices and Radiological 
Health

OMB Control Number 0910-0678--Extension

    FDA is authorized by section 1003(d)(2)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational 
and public information programs. FDA must conduct needed research to 
ensure that such programs have the highest likelihood of being 
effective. Improving communications by FDA's CDRH involves many 
research methods, including individual indepth interviews, mall-
intercept interviews, focus groups, self-administered surveys, 
gatekeeper reviews, and omnibus telephone surveys.
    The information collected will serve three major purposes. First, 
as formative research it will provide critical knowledge needed about 
target audiences to develop messages and campaigns about product use. 
Knowledge of consumer, caregiver, and healthcare professional decision-
making processes will provide a better understanding of target 
audiences that FDA needs to design effective communication strategies, 
messages, and labels.
    Second, as initial testing, the collected information will allow 
FDA to assess the potential effectiveness of messages and materials in 
reaching and successfully communicating with intended audiences. 
Testing messages with a sample of the target audience will allow FDA to 
refine messages while still in the developmental stage. Respondents 
will be asked to give their reaction to the messages in either 
individual or group settings.
    Third, as evaluative research, the collected information will allow 
FDA to ascertain the effectiveness of the messages and the distribution 
method in achieving the objectives of the message campaign. Evaluation 
of message campaigns is a vital link in continuous improvement of 
communications at FDA.
    FDA expects to conduct studies under this generic information 
collection using a variety of research methods. We estimate that the 
burden to respondents will average 16 minutes each (varying from 5 
minutes to 90 minutes). FDA estimates the burden of this collection of 
information based on prior experience with the various types of data 
collection methods described earlier.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 66194]]



                                 Table 1--Estimated Annual Reporting Burden 1 2
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                                                   Number of
   Type of respondent/survey       Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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                                                 General Public
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Individual indepth interviews.             420               1             420  0.75 (45                     315
                                                                                 minutes).
General public focus group                 288               1             288  1.50 (1 hour, 30             432
 interviews.                                                                     minutes).
Intercept interviews: central              200               1             200  0.25 (15                      50
 location.                                                                       minutes).
Intercept interviews:                    4,000               1           4,000  0.08 (5 minutes)             320
 telephone.
Self-administered surveys.....           2,400               1           2,400  0.25 (15                     600
                                                                                 minutes).
Gatekeeper reviews............             400               1             400  0.50 (30                     200
                                                                                 minutes).
Omnibus surveys...............           1,200               1           1,200  0.17 (10                     204
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total (general public)....  ..............  ..............  ..............  ................           2,121
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                                             Healthcare Professional
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Healthcare professional                     72               1              72  0.75 (45                      54
 individual indepth interviews.                                                  minutes).
Healthcare professional focus              144               1             144  1.50 (1 hour, 30             216
 group interviews.                                                               minutes).
                               ---------------------------------------------------------------------------------
    Total (healthcare           ..............  ..............  ..............  ................             270
     professional).
        Total (overall).......  ..............  ..............  ..............  ................           2,391
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers have been rounded.

    Over the next 3-year approval period, we anticipate increasing our 
capability to conduct more communication surveys, which aligns with 
CDRH's strategic priorities. We have adjusted our burden estimates 
accordingly. Additionally, we have added an estimated hour burden for 
``healthcare professional individual indepth interviews.'' These 
changes reflect an overall increase of 315 burden hours and a 
corresponding increase of 276 responses annually.

    Dated: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23781 Filed 11-1-22; 8:45 am]
BILLING CODE 4164-01-P


