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: 0910-0629	ICR Reference No: 200712-0910-011
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/09/2008
	Date Received in OIRA: 12/20/2007
Terms of Clearance: This information collection request is approved consistent with FDA's agreed-upon revisions in its 9/9/2008 memo.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2011	36 Months From Approved
Responses	1	0	0
Time Burden (Hours)	1	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	1	1
Annual Time Burden (Hours)	1	1
Annual Cost Burden (Dollars)	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: No

Burden Reduction Due to:

Short Statement: There is no burden associated with this information collection as FDA believes that it is usual and customary to the respondents. We are estimating one burden hour for the purposes of entering this ICR in ICRAS and ROCIS.

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