View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0606	ICR Reference No: 201009-0910-006
Status: Historical Active	Previous ICR Reference No: 200707-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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: 02/27/2011
	Date Received in OIRA: 09/30/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2014	36 Months From Approved	02/28/2011
Responses	719,040	0	766,540
Time Burden (Hours)	929,140	0	1,085,570
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	719,040	766,540	-47,500
Annual Time Burden (Hours)	929,140	1,085,570	-156,430
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: The program change (decrease ) is due to agency discretion. The one time burden estimate of 156,430 hours associated with a final rule, June 25,2007 (72 FR 34752)has been discontinued

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