Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices

Forms and Documents

Document Name	Status
0769 Supporting Statement Part A 2020.docx Supporting Statement A	2020-10-15

IC Document Collections

IC ID	Document Title	Status
211628	Electronic Submission of Voluntary Allegations to CDRH Instruction	Modified

ICR Details

OMB Control No: 0910-0769	ICR Reference No: 202010-0910-008
Status: Active	Previous ICR Reference No: 201708-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/23/2020
	Date Received in OIRA: 10/16/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2023	36 Months From Approved	11/30/2020
Responses	1,600	0	700
Time Burden (Hours)	400	0	175
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 24 USC 241 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 7562	02/10/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 55300	09/10/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

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

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ICR Summary of Burden

	Total Approved	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	1,600	700	0	0	900	0
Annual Time Burden (Hours)	400	175	0	0	225	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $810,915

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 10/16/2020

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