Submission to CDRH Allegations of Regulatory Misconduct Associated with Medical Devices

ICR 202310-0910-001

OMB: 0910-0769

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2023-10-11
IC Document Collections
ICR Details
0910-0769 202310-0910-001
Received in OIRA 202010-0910-008
HHS/FDA CDRH
Submission to CDRH Allegations of Regulatory Misconduct Associated with Medical Devices
Extension without change of a currently approved collection   No
Regular 10/12/2023
  Requested Previously Approved
36 Months From Approved 11/30/2023
2,500 1,600
625 400
0 0

This ICR collects information voluntarily submitted to the Center for Devices and Radiological Health (CDRH) on s allegations of regulatory misconduct associated with medical devices. Allegations may be related to the sale of unapproved or uncleared medical devices, false claims, or inappropriate advertising. Because there has been no established guidelines or instructions on how to submit allegations of misconduct to CDRH, such 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 allegations of regulatory misconduct that will enhance our timeliness in receiving, assessing and evaluating this voluntary information. 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.

US Code: 24 USC 241 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  88 FR 38061 06/12/2023
88 FR 70666 10/12/2023
Yes

1
IC Title Form No. Form Name
Electronic Submission of Voluntary Allegations to CDRH

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 2,500 1,600 0 0 900 0
Annual Time Burden (Hours) 625 400 0 0 225 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have increased our estimate of burden by 900 responses and 225 hours. We attribute the adjustment to improved efficiencies regarding the tracking of submissions.

$1,190,244
No
    Yes
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
10/12/2023


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