View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0563	ICR Reference No: 201501-0910-001
Status: Historical Active	Previous ICR Reference No: 201109-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
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: 04/06/2015
	Date Received in OIRA: 01/08/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	36 Months From Approved	04/30/2015
Responses	3	0	2
Time Burden (Hours)	68	0	68
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	3	2	1
Annual Time Burden (Hours)	68	68	0
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The increased burden is the result of adding the request for Tier-Two Dispute Resolution to the burden chart.

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