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: 0910-0511	ICR Reference No: 200305-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Device User Fee Cover Sheet - FDA Form 3601
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: 08/06/2003
	Date Received in OIRA: 05/29/2003
Terms of Clearance: This collection is approved under the following conditions: 1) FDA recognizes that collecting this information before OMB approval is a violation of the Paperwork Reduction Act, and will report this violation in the next Information Collection Budget. 2) FDA will update the online version of the form and instructions to include the PRA mandated disclosure statement such as the collection's OMB number, expiration date and expected burden.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2006	08/31/2006
Responses	5,000	0	0
Time Burden (Hours)	1,500	0	0
Cost Burden (Dollars)	0	0	0

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