[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Pages 54727-54728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-21725]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1219]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Survey of Health Care Practitioners for Device 
Labeling Format and Content

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the proposed information collection 
``Survey of Health Care Practitioners for Device Labeling Format and 
Content.''

DATES: Submit either electronic or written comments on the collection 
of information by November 12, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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

[[Page 54728]]

proposed 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.

Survey of Health Care Practitioners for Device Labeling Format and 
Content--21 CFR Part 801 (OMB Control Number 0910-NEW)

    The purpose of this study is to compare existing device labeling 
from approximately six different types of medical devices with a 
standard content and format of the same labeling that FDA researchers 
will develop using the existing labeling as their source of the 
information.
    Building upon the research methodology and success of the approach 
FDA used to evaluate drug labeling, we propose to measure the usability 
and usefulness of a draft standard content and format of device 
labeling against existing manufacturer labeling of the same device. 
This will support our research that has already been done to assess 
whether health care practitioners (HCPs) find the format and content of 
device labeling to be clear, understandable, useful, and user friendly 
(OMB control number 0910-0715). Findings will provide evidence to 
inform FDA's planned regulatory approach to standardizing medical 
device labeling across the United States.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
                                     Number of    responses      Total       Average       Total       Capital
        Type of respondent          respondents      per         annual    burden  per     hours        costs
                                                  respondent   responses     response
----------------------------------------------------------------------------------------------------------------
HCPs participating at a hospital..            8            1            8            2           16
HCPs participating at FDA.........           30            1           30            4          120         $600
                                   -----------------------------------------------------------------------------
    Total.........................  ...........  ...........  ...........  ...........          136          600
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    We will conduct the studies at three different sites including two 
area hospitals using their devices, existing labeling, and HCPs. We 
expect that the maximum time for testing will be 2 hours. Given a 
sample of 6 devices with 2 different labeling types, there will be 12 
different labeling types to be tested. We plan to have eight people 
test each type of the labeling.
    We will also conduct the studies on FDA's campus using medical 
devices received from medical device industry representatives through a 
material transfer agreement. To account for travel time and cost, we 
have included 2 additional hours and $20 per respondent in the burden 
estimate for HCPs participating at FDA.

    Dated: September 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21725 Filed 9-11-14; 8:45 am]
BILLING CODE 4164-01-P