View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0513	ICR Reference No: 201611-0910-004
Status: Historical Active	Previous ICR Reference No: 201608-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/23/2016
	Date Received in OIRA: 11/22/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	09/30/2019	09/30/2019
Responses	1,499	0	1,499
Time Burden (Hours)	19,780	0	19,780
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	1,499	1,499
Annual Time Burden (Hours)	19,780	19,780
Annual Cost Burden (Dollars)	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 information collection reflects an increase attributed to an increased number of respondents subject to the submissions.

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