[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67459-67460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28241]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
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,
[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 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
follows:
[[Page 67460]]
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 .5 60
Advanced practice nurses (NPs) 240 1 240 .5 120
and registered nurses..........
Medical technicians............. 240 1 240 .5 120
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Total....................... .............. .............. .............. .............. 324
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28241 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P