Document ID: FDA-2017-N-1095-0007
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: 2020-09-04T04:00Z

[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Notices]
[Pages 55300-55301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19563]

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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: Submit written comments (including recommendations) on the 
collection of information by October 5, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0769. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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 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, prior to the

[[Page 55301]]

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 February 10, 2020 (85 FR 7562), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments.
    The first comment was not relevant to the information collection.
    The second comment stated that the rule does not state whether 
people submitting allegations of regulatory misconduct are required to 
redact their contact information.
    We disagree with the comment. Anyone may file a complaint reporting 
an allegation of regulatory misconduct. FDA encourages people 
submitting allegations to include supporting information and contact 
information in case additional information is needed for FDA to 
understand the allegation and act on the report; however, you can 
choose to submit a report anonymously. FDA will not share your identity 
or contact information with anyone outside FDA unless required to do so 
by law, regulation, or court order.
    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
----------------------------------------------------------------------------------------------------------------
Electronic submission of                 1,600               1           1,600  0.25 (15                     400
 voluntary allegations to CDRH.                                                  minutes).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall increase of 225 hours and a corresponding increase of 900 
responses/records. We attribute this adjustment to an increase in the 
number of submissions we received over the last few years.

    Dated: August 26, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-19563 Filed 9-3-20; 8:45 am]
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