View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0624	ICR Reference No: 201412-0910-008
Status: Historical Active	Previous ICR Reference No: 200806-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Final Rule
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 without change	Conclusion Date: 02/06/2015
	Date Received in OIRA: 12/11/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved
Responses	19,480	0	0
Time Burden (Hours)	1,590,400	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to New Statute	Change Due to Agency Discretion
Annual Number of Responses	19,480	8,232	11,248
Annual Time Burden (Hours)	1,590,400	422,495	1,167,905
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: This is a new data collection.

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