View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0154	ICR Reference No: 201102-0910-005
Status: Historical Inactive	Previous ICR Reference No: 200712-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 04/25/2011
	Date Received in OIRA: 02/22/2011
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB considers this information collection request to be improperly submitted. OMB notes that this collection lists a decrease in responses of 931,500 due to error in agency estimate. The decrease is not explained in the agency's supporting statement and, thus, there is insufficient information to evaluate this request. Please resumbit with a description of how such a large error in estimate occured.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	06/30/2011
Responses	1,082,150	0	1,082,150
Time Burden (Hours)	157,550	0	157,550
Cost Burden (Dollars)	0	0	0

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