View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0154	ICR Reference No: 201406-0910-017
Status: Historical Active	Previous ICR Reference No: 201104-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
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: Approved without change	Conclusion Date: 08/27/2014
	Date Received in OIRA: 06/30/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	08/31/2014
Responses	85,150	0	150,650
Time Burden (Hours)	89,050	0	157,550
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	85,150	150,650	-65,500
Annual Time Burden (Hours)	89,050	157,550	-68,500
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is an extension of a currently approved collection and reflects a decrease in the number of respondents. This adjustment is explained in the agency's supporting statement, Part A, at question 15.

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