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View ICR - OIRA Conclusion

OMB Control No: 0910-0513	ICR Reference No: 201309-0910-011
Status: Historical Active	Previous ICR Reference No: 201007-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 20536
Title: Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
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: 10/23/2013
	Date Received in OIRA: 09/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2016	36 Months From Approved	10/31/2013
Responses	1,075	0	1,006
Time Burden (Hours)	13,820	0	14,120
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	1,075	1,006	69
Annual Time Burden (Hours)	13,820	14,120	-300
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: The estimated burden hours for this information collection has decreased from 14,120 hours to 13,830 hours. As described in #12 of the Supporting Statement, this decrease is the result of new data and projections on the number of forms we have received and will receive.

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