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: 0910-0667	ICR Reference No: 201001-0910-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Current Good Manufacturing Practices for Positron Emission Tomography Drugs
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 without change	Conclusion Date: 09/27/2010
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/28/2010
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved. The agency is reminded that they must submit any collection associated with a rulemaking on or before the date of publication in the final register. This includes both proposed and final rulemakings. Should the agency forget to do so in the future, they may cause unnecessary delay in the implementation of their rule.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2013	36 Months From Approved
Responses	101	0	0
Time Burden (Hours)	90,216	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to New Statute
Annual Number of Responses	101	101
Annual Time Burden (Hours)	90,216	90,216
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: This is a new regulation.