
[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Pages 12597-12598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0766]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Survey of ``Health 
Care Providers' Responses to Medical Device Labeling''

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 April 
2, 2012.

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-NEW and 
title ``Survey of `Health Care Providers' Responses to Medical Device 
Labeling' ''). 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.

Survey of ''Health Care Providers' Responses to Medical Device 
Labeling''--21 CFR Part 801 (OMB Control Number 0910-NEW)

    The purpose of this study is to determine the most effective device 
labeling format and inform an FDA's regulatory approach on standardized 
device labeling. Building upon the research methodology and success of 
the approach FDA used to evaluate drug labeling, we propose to ask 
health care providers (HCPs) to evaluate the quality of labeling (e.g. 
instructions for use, directions) for a medical device and to report 
the degree to which they could follow those instructions, how useful 
the information is, and how well organized the information is. This 
work will allow FDA to assess whether HCPs find the format and content 
of device labeling clear, understandable, useful, and user-friendly. 
Findings will provide evidence to inform FDA's regulatory approach to 
standardizing medical device labeling across the United States.
    In the Federal Register of November 1, 2011 (76 FR 67459), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information.
    Two comments were received, however only one was related to the 
Paperwork Reduction Act of 1995. In response to the comments submitted 
by Advamed, FDA responses are as follows:
    (Comment 1) Comment 1 questioned whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility.
    (Response) The survey is designed to elicit responses on the 
formatting, content, and design of the template and not on the specific 
medical device chosen. This is stated at the beginning of the survey. 
FDA relies upon knowledgeable researchers to develop appropriate survey 
tools, and the research methodology to test content, format, and design 
of labeling is based on their expertise. Drugs instructions are written 
for all users, including health care providers and patients. The device 
labeling is written for all users, including health care providers and 
patients. We agree that industry could provide recommended contents and 
formats of labeling and encourage industry to do so. This survey is 
designed for the health care provider and their feedback.
    (Comment 2) Comment 2 questioned the accuracy of FDA's estimate of 
the burden of the proposed collection of information, including the 
validity of the methodology and assumptions used.
    (Response) The survey is designed to elicit responses on the 
formatting, content, and design of the template and not on the specific 
medical device chosen. The terms used in the templates such as 
``warnings'', ``contraindications'', and ``brand name'' are commonly 
used terms in labeling for all devices. We are addressing what should 
be in a shortened version of labeling that will allow the user to 
operate it safely. The survey was designed by researchers with 
extensive knowledge in the area of testing labeling. It is anticipated 
that different health care practitioners will provide different answers 
based on their experiences; this is why we chose to ask various types 
of health care practitioners. The objective of the survey is to improve 
device labeling; it would not be possible to do a survey with a 
fictitious device that has no intended use as per the suggestion. All 
devices need to have intended use.
    (Comment 3) Comment 3 questioned ways to enhance the quality, 
utility, and clarity of the information to be collected.
    (Response) We did not choose biomedical engineers as part of this 
survey because we wanted the people who interact with the pump in the 
presence of patients. The suggestion to add a question about whether a 
health care professional ever uses or reads device labeling and how to 
improve access to current device labeling was done in a previous study 
with focus groups. We developed the template survey based on the 
responses we

[[Page 12598]]

received in those focus group sessions. We agree that responses will 
vary depending on the professional group and anticipate this. We 
developed this survey with professional researchers who develop 
surveys, and this was also tested internally. We trust that the 
questions and how they are asked are what we need in order to inform 
any further actions on medical device labeling content and format 
development. In regard to conducting objective usability tests with a 
range of medical device types, we encourage others to perform these 
types of tests and share the results with FDA.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
           Respondents               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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                                                   Interviews
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Physicians......................               6               1               6               1               6
Advanced practice nurses (NPs)                 9               1               9               1               9
 and registered nurses..........
Medical technicians.............               9               1               9               1               9
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    Subtotal....................              24               1              24               1              24
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                                                     Survey
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Physicians......................             120               1             120             0.5              60
Advanced practice nurses (NPs)               240               1             240             0.5             120
 and registered nurses..........
Medical technicians.............             240               1             240             0.5             120
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    Total.......................             624               1             624             0.5             324
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 27, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-4969 Filed 2-29-12; 8:45 am]
BILLING CODE 4160-01-P


