[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Pages 67459-67460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28241]



Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Survey of ``Health Care Providers' Responses to 
Medical Device Labeling''

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 this proposed information collection 
``Health Care Providers' Responses to Medical Device Labeling.''

DATES: Submit either electronic or written comments on the collection 
of information by January 3, 2012.

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.

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-5156, 

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 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 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.
    FDA estimates the burden of this collection of information as 

[[Page 67460]]

                                 Table 1--Estimated Annual Reporting Burden \1\
                                                     Number of                        Average
           Respondents               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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
    Subtotal....................              24               1              24               1              24
Physicians......................             120               1             120              .5              60
Advanced practice nurses (NPs)               240               1             240              .5             120
 and registered nurses..........
Medical technicians.............             240               1             240              .5             120
    Total.......................  ..............  ..............  ..............  ..............             324
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: October 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28241 Filed 10-31-11; 8:45 am]