Document ID: FDA-2013-N-0485-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Electronic
Submission Process for Voluntary Allegations to the Center for Devices
and Radiological Health
Posted Date: 2014-05-23T04:00Z

[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29779-29780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11922]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0485]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Electronic Submission 
Process for Voluntary Allegations 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 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 June 
23, 2014.

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 ``Electronic Submission 
Process for Voluntary Allegations to the Center for Devices and 
Radiological Health.'' 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.

Electronic Submission Process for Voluntary Allegations to the Center 
for Devices and Radiological Health--(OMB Control Number 0910-NEW)

    This information collection request 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 an allegation 
to CDRH, allegations 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 allegations that will enhance our timeliness in receiving, 
assessing and evaluating voluntary allegations. The information 
provided in the allegations 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.
    In the Federal Register of May 6, 2013 (78 FR 26373), FDA published 
a 60-day notice requesting public comment on the proposed collection of 
information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 29780]]

                                  Table 1--Estimated Annual Reporting Burden\1\
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    Allegation                            Number of
    reporting          Number of        responses per       Total annual     Average  burden      Total hours
    respondent        respondents         respondent         responses        per  response
----------------------------------------------------------------------------------------------------------------
                               700                  1                700             \2\.25                175
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 15 minutes.

    Dated: May 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11922 Filed 5-22-14; 8:45 am]
BILLING CODE 4160-01-P