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View ICR - OIRA Conclusion

OMB Control No: 0910-0622	ICR Reference No: 200804-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Foreign Clinical Studies Not Conducted Under an IND
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: Preapproved	Conclusion Date: 04/17/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/17/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2011	36 Months From Approved
Responses	575	0	0
Time Burden (Hours)	18,400	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Request	Change Due to New Statute
Annual Number of Responses	575	575
Annual Time Burden (Hours)	18,400	18,400
Annual Cost Burden (Dollars)	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: No

Burden Reduction Due to:

Short Statement: The final rule replaces the requirement that non-IND foreign studies be conducted in accordance with the 1989 Declaration with a requirement to conduct such studies in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC).