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: 0910-0616	ICR Reference No: 200809-0910-001
Status: Historical Active	Previous ICR Reference No: 200712-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/21/2008
	Date Received in OIRA: 09/08/2008
Terms of Clearance: This ICR is approved for 3 years. During that time, FDA should continue to work with respondents to ensure that they understand these new requirements and when they are applicable. FDA will also continue to evaluate whether there are additional ways to minimize respondent burden with regards to routine filings which may not require certification.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2011	36 Months From Approved	10/31/2008
Responses	54,782	0	54,782
Time Burden (Hours)	24,420	0	24,420
Cost Burden (Dollars)	0	0	0

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