[Federal Register Volume 85, Number 27 (Monday, February 10, 2020)]
[Notices]
[Pages 7566-7567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02531]



[[Page 7566]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Testing 
Communications on Medical Devices and Radiation-Emitting Products

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.

DATES: Fax written comments on the collection of information by March 
11, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0678. 
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.

Testing Communications on Medical Devices and Radiation-Emitting 
Products

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 relating to the safety of regulated 
medical devices and radiation-emitting products. FDA must conduct 
needed research to ensure that such programs have the highest 
likelihood of being effective. Improving communications about medical 
devices and radiation emitting products will involve 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 medical device 
and radiation-emitting product use. Knowledge of consumer and 
healthcare professional decision-making processes will provide the 
better understanding of target audiences that FDA needs to design 
effective communication strategies, messages, and labels. These 
communications will aim to improve public understanding of the risks 
and benefits of using medical devices and radiation-emitting products 
by providing users with a better context in which to place risk 
information more completely.
    Second, as initial testing, it will allow FDA to assess the 
potential effectiveness of messages and materials in reaching and 
successfully communicating with their 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, it will allow FDA to ascertain the 
effectiveness of the messages and the distribution method of these 
messages in achieving the objectives of the message campaign. 
Evaluation of campaigns is a vital link in continuous improvement of 
communications at FDA.
    Annually, FDA projects conducting about 30 studies using a variety 
of research methods and lasting an average of 0.17 hours each (varying 
from 0.08 to 1.5 hours). FDA estimates the burden of this collection of 
information based on prior experience with the various types of data 
collection methods described earlier. FDA is requesting this burden so 
as not to restrict the Agency's ability to gather information on public 
sentiment for its proposals in its regulatory and communications 
programs.
    In the Federal Register of November 15, 2019 (84 FR 62541), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Individual Indepth Interviews.             360               1             360  0.75 (45                     270
                                                                                 minutes).
General Public Focus Group                 144               1             144  1.5.............             216
 Interviews.
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  0.5 (30 minutes)             200
Omnibus Surveys...............           1,200               1           1,200  0.17 (10                     204
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total (General Public)....           8,704  ..............           8,702  ................           1,860
Physician Focus Group                      144               1             144  1.5.............             216
 Interviews.
                               ---------------------------------------------------------------------------------
    Total (Physician).........             144  ..............  ..............  ................             216
                               ---------------------------------------------------------------------------------
    Total (Overall)...........           8,848  ..............  ..............  ................           2,076
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 7567]]

    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: February 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02531 Filed 2-7-20; 8:45 am]
 BILLING CODE 4164-01-P


