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View ICR - OIRA Conclusion

OMB Control No: 0910-0645	ICR Reference No: 201409-0910-012
Status: Historical Active	Previous ICR Reference No: 201310-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Electronic Submission of FDA Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/16/2014
	Date Received in OIRA: 09/23/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2016	04/30/2016	04/30/2016
Responses	1,494,577	0	1,494,577
Time Burden (Hours)	897,001	0	897,001
Cost Burden (Dollars)	0	0	0

Authorizing Statute(s): US Code: 21 USC 355 Name of Law: FFDCA
   US Code: 21 USC 357 Name of Law: FFDCA
   US Code: 21 USC 360 Name of Law: FFDCA
   US Code: 21 USC 393 Name of Law: FFDCA
   US Code: 21 USC 301 Name of Law: FFDCA
   PL: Pub.L. 109 - 462 120 Name of Law: DSNDCPA
   PL: Pub.L. 110 - 85 1005 Name of Law: FDAAA

Citations for New Statutory Requirements: None

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