Document ID: FDA-2010-N-0344-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Testing Communications on Medical Devices and Radiation-Emitting Products
Posted Date: 2010-10-18T04:00Z

[Federal Register: October 18, 2010 (Volume 75, Number 200)]
[Notices]               
[Page 63838-63839]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc10-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0344]

 
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 
November 17, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
the title ``Testing Communications on Medical Devices and Radiation-
Emitting Products.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@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-NEW)

    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

[[Page 63839]]

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 health 
care professional decisionmaking 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 about 30 studies using a variety of research 
methods and lasting an average of 0.17 hours each (varying from 0.08-
1.5 hours). The operating and maintenance costs include contractor 
expenses for designing and conducting information collection 
activities, specifically, drawing samples, training interviewers, 
collecting and analyzing information, and reporting and disseminating 
findings. FDA estimates the burden of this collection of information 
based on prior recent 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 July 13, 2010 (75 FR 39952), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment, however it was not 
related to the collection of information.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
   Anticipated data collection       Number of     frequency per   Total annual      Hours per      Total hours
             methods                respondents      response        responses       response
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Individual indepth interviews...             360               1             360             .75             270
General public focus group                   144               1             144            1.5              216
 interviews.....................
Intercept interviews: Central                600               1             600             .25             150
 location.......................
Intercept interviews: Telephone.      10,000 \2\               1          10,000             .08             800
Self-administered surveys.......           2,400               1           2,400             .25             600
Gatekeeper reviews..............             400               1             400             .50             200
Omnibus surveys.................           2,400               1           2,400             .17             408
                                 -------------------------------------------------------------------------------
    Total (general public)......          16,304  ..............          16,304  ..............           2,644
Physician focus group interviews             144               1             144            1.5              216
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    Total (physician)...........             144  ..............             144  ..............             216
                                 -------------------------------------------------------------------------------
        Total (overall).........          16,448  ..............          16,448  ..............           2,860
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Brief interviews with callers to test message concepts and strategies following their call-in request to an
  FDA Center 1-800 number.

    Dated: October 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26119 Filed 10-15-10; 8:45 am]
BILLING CODE 4160-01-P