Medical Devices; Reports of Corrections and Removals

Forms and Documents

Document Name	Status
0359 device corrections and removals SSA 2020 REV wChange.docx Supporting Statement A	2020-10-09

IC Document Collections

IC ID	Document Title	Status
5979	Device corrections and removals	Modified
243391	eSubmitter participants Other-eSubmitter screenshots	New
243390	Combination product reports and recordkeeping	New

ICR Details

OMB Control No: 0910-0359	ICR Reference No: 202008-0910-010
Status: Active	Previous ICR Reference No: 201706-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Reports of Corrections and Removals
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/09/2020
	Date Received in OIRA: 08/31/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2023	36 Months From Approved	10/31/2020
Responses	1,686	0	1,033
Time Burden (Hours)	13,115	0	14,408
Cost Burden (Dollars)	25,850	0	30,660

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Abstract: The information collection requirements in 21 CFR Part 806 require each device manufacturer or importer to submit a written report to FDA of any action to correct or remove a device which may present a risk to health within 10-working days of initiating such correction or removal. The Information Collection also requires that each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA, shall keep a record of such correction or removal.

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Authorizing Statute(s): US Code: 21 USC 360i(g) Name of Law: FFDCA; Records and Reports on Devices
  

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 10168	02/21/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 51451	08/20/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Device corrections and removals
Combination product reports and recordkeeping
eSubmitter participants

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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	1,686	1,033	0	0	653	0
Annual Time Burden (Hours)	13,115	14,408	0	0	-1,293	0
Annual Cost Burden (Dollars)	25,850	30,660	0	0	-4,810	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: The information collection reflects revision and adjustment. We have revised the collection to include reporting and recordkeeping resulting from provisions associated with combination products established by rulemaking (0910-AF82). At the same time, upon review we noted calculation errors in our last submission. Cumulatively these changes result in 653 additional responses, 1,293 fewer burden hours, and a reduction of $4,810 in costs.

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Annual Cost to Federal Government: $1,841,658

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.     No

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: 08/31/2020

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