Document ID: FDA-2013-N-0796-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Testing
Communications on Medical Devices and Radiation-Emitting Products
Posted Date: 2013-12-19T05:00Z

[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Pages 76841-76842]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30149]

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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 January 
21, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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 health 
care 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 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). 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 9, 2013 (78 FR 41066), 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:

[[Page 76842]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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Individual indepth interviews...............             360               1             360  0.75 (45 minutes).........................             270
General public focus group interviews.......             144               1             144  1.50 hours................................             216
Intercept interviews: Central location......             200               1             200  0.25 (15 minutes).........................              50
Intercept interviews: Telephone.............           4,000               1           4,000  0.08 (5 minutes)..........................             320
Self-Administered surveys...................           2,400               1           2,400  0.25 (15 minutes).........................             600
Gatekeeper reviews..........................             400               1             400  0.50 (30 minutes).........................             200
Omnibus surveys.............................           1,200               1           1,200  0.17 (10 minutes).........................             204
                                             -----------------------------------------------------------------------------------------------------------
    Total (general public)..................           8,704  ..............  ..............  ..........................................           1,860
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Physician focus group interviews............             144               1             144  1.50 hours................................             216
                                             -----------------------------------------------------------------------------------------------------------
    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.

    Dated: December 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30149 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P