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View ICR - OIRA Conclusion

OMB Control No: 0910-0645	ICR Reference No: 201602-0910-009
Status: Historical Active	Previous ICR Reference No: 201409-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: AGENCY WIDE
Title: FDA Adverse Event Reports; Electronic Submissions
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/04/2016
	Date Received in OIRA: 02/29/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2019	36 Months From Approved	05/31/2016
Responses	1,867,657	0	1,494,577
Time Burden (Hours)	1,120,849	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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	1,867,657	1,494,577	273	372,807
Annual Time Burden (Hours)	1,120,849	897,001	164	223,684
Annual Cost Burden (Dollars)	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Burden changes reflect fluctuations in adverse event reporting and new electronic reporting features. These changes are discussed more fully in the agency's supporting statement.

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