View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0700	ICR Reference No: 201107-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/06/2012
	Date Received in OIRA: 07/07/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved
Responses	2,133	0	0
Time Burden (Hours)	27,186	0	0
Cost Burden (Dollars)	63,990	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	2,133	2,133
Annual Time Burden (Hours)	27,186	27,186
Annual Cost Burden (Dollars)	63,990	63,990

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: FDA will begin a voluntary pilot program as described in this guidance document and will evaluate the outcomes of the pilot program at the end of this period. The proposed collections of information are necessary to satisfy the previously mentioned statutory requirements for implementing this voluntary submission pilot program.

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