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View ICR - OIRA Conclusion

OMB Control No: 0910-0700	ICR Reference No: 201412-0910-004
Status: Historical Active	Previous ICR Reference No: 201107-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/18/2015
	Date Received in OIRA: 01/12/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	2,267	0	2,133
Time Burden (Hours)	28,914	0	27,186
Cost Burden (Dollars)	68,010	0	63,990

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	2,267	2,133	134
Annual Time Burden (Hours)	28,914	27,186	1,728
Annual Cost Burden (Dollars)	68,010	63,990	4,020

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: The number of respondents for "First year, electronic set-up and verification certificate" has increased from 1,600 to 1,700. The number of respondents for "Audit report submission" has increased from 1,600 to 1,700.

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