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View ICR - OIRA Conclusion

OMB Control No: 0910-0748	ICR Reference No: 201703-0910-003
Status: Historical Active	Previous ICR Reference No: 201401-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/18/2017
	Date Received in OIRA: 03/15/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2020	36 Months From Approved	05/31/2017
Responses	745	0	738
Time Burden (Hours)	1,760	0	1,746
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	745	738	7
Annual Time Burden (Hours)	1,760	1,746	14
Annual Cost Burden (Dollars)	0	0	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: We made a minor adjustment to the number of respondents which caused a 14-hour increase in the total burden estimate.

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