Medical Devices; Reports of Corrections and Removals

Forms and Documents

Document	Type	Status	Availability
Form 806 Medical Devices; Reports of Corrections and Removals	Form and Instruction	Modified	Available
0359 ss 3-19-14.doc	Supporting Statement A	Uploaded 2014-04-03	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5979	Medical Devices; Reports of Corrections and Removals	Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0359	ICR Reference No: 201404-0910-006
Status: Historical Active	Previous ICR Reference No: 201103-0910-007
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: 07/03/2014
	Date Received in OIRA: 04/08/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	36 Months From Approved	07/31/2014
Responses	1,033	0	756
Time Burden (Hours)	14,408	0	7,560
Cost Burden (Dollars)	30,660	0	0

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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: null
  

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:
	78 FR 38992	06/28/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 17549	03/28/2014
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
Medical Devices; Reports of Corrections and Removals	806	Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products

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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	1,033	756	0	0	277	0
Annual Time Burden (Hours)	14,408	7,560	0	5,918	930	0
Annual Cost Burden (Dollars)	30,660	0	0	30,660	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: Adjustments: The average annual number of reporting respondents has increased since the last approval from 666 to 1,033. This adjustment resulted in an increase of 3,670 hours to the reporting burden. The average annual number of recordkeeping respondents has increased since the last approval from 90 to 93. This adjustment resulted in an increase of 30 hours to the recordkeeping burden. Revision: Additionally, FDA is revising this ICR making available an electronic Web-based process for submitting reports of corrections and removals. We have therefore added a line-item to the reporting burden table for set-up of the electronic process. This resulted in an additional increase of 5,918 hours. We have also accounted for the purchase of a 1 to 3 year digital verification certificate for respondents who use the new electronic process. This has resulted in an increase of $30,660 in the operating and maintenance cost.

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Annual Cost to Federal Government: $1,467,424

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 04/08/2014

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