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: 0910-0635	ICR Reference No: 200809-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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: 05/29/2009
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/26/2008
Terms of Clearance: OMB approves this previously unapproved collection under the following conditions: 1) Since this information was collected without OMB approval, it will need to be reported as a violation in the next ICB. 2) In the future, FDA must correctly identify these types of request in ROCIS as an existing collection in use without an OMB number and not as a new collection. Otherwise, OMB will return as improperly submitted.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2012	36 Months From Approved
Responses	828	0	0
Time Burden (Hours)	1,490	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to New Statute
Annual Number of Responses	828	828
Annual Time Burden (Hours)	1,490	1,490
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 collection. The increase in reporting and recordkeeping burdens reflect our estimate of the number of serious adverse events related to dietary supplements that would need to be reported to FDA annually; this burden includes any follow-up medical information and the associated recordkeeping regarding the event.