[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]


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

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.

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

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                700                1              700          .25 (15              125
                                                                                                                              minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-P