Document ID: FDA-2017-N-1095-0002
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: 2017-08-23T04:00Z

[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Page 40006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17836]

[[Page 40006]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1095]

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 
September 22, 2017.

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 OMB control number 0910-0769. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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 0910-0769--
Extension

    This information collection request collects information 
voluntarily submitted to 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, prior to the 
establishment of the electronic submission process for voluntary 
allegations to CDRH, there had been no established guidelines or 
instructions on how to submit an allegation to CDRH, allegations often 
contained minimal information and were received via phone calls, 
emails, or conversationally. CDRH has established a consistent format 
and process for the submission of device allegations that enhances 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 30, 2017 (82 FR 24716) 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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                               Number of
                 Activity                     Number of      responses per     Total annual          Average burden per  response          Total hours
                                             respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic submission of voluntary                    700                1              700   .25 (15 minutes).........................             175
 allegations to CDRH.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17836 Filed 8-22-17; 8:45 am]
BILLING CODE 4164-01-P