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View ICR - OIRA Conclusion

OMB Control No: 0910-0641	ICR Reference No: 201602-0910-011
Status: Historical Active	Previous ICR Reference No: 201303-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Q. & Answers Re: Labeling of Nonprescription Human Drug Products Marketed w/o an Approved App as Required by the Dietary Supp & Nonpresription Drug Consumer Protection Act
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: 06/20/2016
	Date Received in OIRA: 03/02/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	06/30/2016
Responses	900	0	100,000
Time Burden (Hours)	3,600	0	400,000
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	900	100,000	-99,100
Annual Time Burden (Hours)	3,600	400,000	-396,400
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: There is a significant adjustment in burden for this ICR from 400,000 to 3,600 total burden hours. This adjustment was required to eliminate double-counting of burden hours discovered in OMB Control #0910-0641 and 0910-0340. For 0910-0641, we have limited the third party disclosure burden to new OTC drug products marketed without approved new drug applications.

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