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View ICR - OIRA Conclusion

OMB Control No: 0910-0442	ICR Reference No: 201409-0910-021
Status: Historical Active	Previous ICR Reference No: 201105-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Device Tracking
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: 02/03/2015
	Date Received in OIRA: 10/27/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	02/28/2015
Responses	613,736	0	17,915
Time Burden (Hours)	615,380	0	621,279
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	613,736	17,915	595,821
Annual Time Burden (Hours)	615,380	621,279	-5,899
Annual Cost Burden (Dollars)	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Upon review of this ICR under the PRA, the burden for "Tracking information-821.25(a)" has been changed from reporting to recordkeeping. This resulted in an adjustment of the reporting burden being decreased by 17,911. As a result of parsing out estmiates for the different ICs, the number of respondents has increased.

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