[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Notices]
[Pages 26373-26374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10597]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0485]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Submission Process for Voluntary Complaints
to the Center for Devices and Radiological Health
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 information voluntarily submitted to the
Center for Devices and Radiological Health (CDRH) on actual or
potential health risk concerns about a medical device or radiological
product or its use.
DATES: Submit either electronic or written comments on the collection
of information by July 5, 2013.
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-
[[Page 26374]]
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.
Electronic Submission Process for Voluntary Complaints to the Center
for Devices and Radiological Health--(OMB Control Number 0910-NEW)
This ICR collects information voluntarily submitted to the Center
for Devices and Radiological Health (CDRH) on actual or potential
health risk concerns about a medical device or radiological product or
its use. Because there has been no established guidelines or
instructions on how to submit a compliant to CDRH, complaints often
contain minimal information and are received via phone calls, emails,
or conversationally from any CDRH staff. CDRH seeks to establish a
consistent format and process for the submission of device complaints
that will enhance our timeliness in receiving, assessing and evaluating
voluntary complaints. The information provided in the complaints
received by CDRH may be used to clarify the recurrence or emergence of
significant device-related risks to the general public and the need to
initiate educational outreach or regulatory action to minimize or
mitigate identified risks.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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700 1 700 .25 (15 125
minutes)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10597 Filed 5-3-13; 8:45 am]
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