
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18410-18411]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07817]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 May 6, 
2015.

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 title Survey of Health Care 
Practitioners for Device Labeling Format and Content. 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.

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.
    In the Federal Register of September 12, 2014 (79 FR 54727), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA used comments from the medical device 
industry, health care professionals, caregivers, and patients to help 
formulate the objectives and define the scope of this study. The 
received comments are followed by FDA's responses as follows:
    (Comment 1) One comment stated that FDA should coordinate with the 
American Society for Testing and Materials (ASTM) as they already have 
published a consensus standard (F2943) on this topic. This standard 
resulted from the work of a multi-stakeholder working group.
    (Response) FDA reviewed the consensus standard (F2943) when we 
drafted the outline for this study. We consulted with a member of the 
ASTM committee. We also requested a member of the committee to be on 
our strategic planning committee for this study.
    (Comment 2) A comment stated that FDA does not follow the guidance 
on formative human factors and usability studies. The guidance provides 
good direction on appropriately choosing representative end users, 
replicating the intended user environment, and evaluating the user-
product interface (see FDA draft guidance ``Applying Human Factors and 
Usability Engineering to Optimize Medical Device Design'' issued on 
June 22, 2011).
    (Response) FDA had designed the protocol for this study with a 
human factors expert and a social scientist. In this particular study, 
we will be doing a cognitive test of the health care practitioners. 
They will be asked to find a piece of information in the draft outline 
of standard content of labeling, or in the manufacturer's existing 
labeling. They will not be interacting with the device and this will be 
a usability test; they will be responding to scenarios to search for 
information.
    (Comment 3) One comment stated that FDA should ask the question, 
particularly to physicians, whether the standard of care requires them 
to read the user instructions and understand the product's warning.
    (Response) This study is the third part of a three-part study. FDA 
performed focus groups of health care practitioners asking them what 
they want in labeling, where do they find labeling, what are the most 
important sections of labeling, and whether they even look at labeling. 
Their responses indicated that they do not look at labeling because it 
is complicated and they typically cannot find the information they want 
in one section. They stated they would like an abbreviated version of 
labeling in order to find use information more easily, they would like 
a standard content of labeling, and they also would like to find it 
electronically and in one place if possible.
    FDA does not regulate the practice of medicine; we do, however, 
regulate labeling that accompanies a device. Based on the previous 
phases of the studies already done, we now want to test a standard 
content of labeling against an existing piece of the same labeling to 
see if health care practitioners can find what they need in a 
consistent and easy way. This is a cognitive testing of a standard 
content of labeling and does not include questions regarding whether or 
not someone is required to read the labeling before using the device.
    We will be using outside experts to develop the protocol, develop 
the scenarios, develop the draft standardized labeling, perform the 
testing, and provide a summary of the study. This is being done through 
the Entrepreneurs in Residence program that is funded by the White 
House to use outside experts and their special knowledge and skills to 
work on an innovative idea that helps the government when faced with a 
unique problem. Dr. Daryle Gardner-Bonneau is a renowned social 
scientist and human factors specialist who has worked with the device 
industry, standards organizations, and the National Research Council on 
issues with medical device labeling. Patricia Kingsley is a former FDA 
employee who worked on medical device labeling issues. Nancy Ostrove is 
a former FDA employee who worked on surveys and studies with drug 
community when the Center for Drug Evaluation and Research was 
developing standardized labeling

[[Page 18411]]

for drugs. Dr. Ruth Day, a social scientist researcher at Duke 
University, has worked as a special government employee on the labeling 
for drugs. Ron Charnock is CEO of Kwikpoint, which is a visual language 
developer for instructions for use. His company worked on a Cooperative 
Research and Development Agreement with the Center for Devices and 
Radiological Health to determine if visual language could be used in 
lieu of words on certain portions of device labeling.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                  Number of
                                     Number of    responses      Total       Average    Total hours    Capital
        Type of respondent          respondents      per         annual     burden per      \1\         costs
                                                  respondent   responses     response
----------------------------------------------------------------------------------------------------------------
Screener..........................           60            1           60         0.08            5  ...........
Health care professionals                    24            1           24          1.5           36  ...........
 participating at a hospital......
Health care professionals                    12            1           12          3.5           42         $240
 participating at FDA.............
                                   -----------------------------------------------------------------------------
    Total.........................  ...........  ...........  ...........  ...........           83         $240
----------------------------------------------------------------------------------------------------------------
\1\ Numbers have been rounded.

    We plan to screen approximately 60 potential respondents prior to 
being included in the study. The screener will be done using email. We 
estimate that the screener will only take approximately 5 minutes per 
person.
    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 1.5 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 24 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 we have 
included 2 additional hours per response in the burden estimate for the 
12 health care professionals participating at FDA.

    Dated: March 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07817 Filed 4-3-15; 8:45 am]
BILLING CODE 4164-01-P


