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OMB Control No: 0910-0645	ICR Reference No: 201301-0910-009
Status: Historical Inactive	Previous ICR Reference No: 201003-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: 18663
Title: Electronic Data Collection Using MedWatchPlus Portal and Rational Questionnaire--21 CFR 310.305, 314.80, 314.98, 514.80, 600.80, 1271.350 and Part 803
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 02/18/2013
	Date Received in OIRA: 01/31/2013
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB considers this ICR to be improperly submitted. The burden data entered into ROCIS does not match the data listed in Question 15 of the Supporting Statement. Please revise the ICR and resubmit it to OMB when ready. Please also consult the terms of clearance listed in the Supporting Statement and submit a memo responding to them on resubmission.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	36 Months From Approved	04/30/2013
Responses	1,365,042	0	1,365,042
Time Burden (Hours)	462,318	0	462,318
Cost Burden (Dollars)	0	0	0

Abstract: FDA is implementing electronic data collection to improve adverse event reporting across the agency. FDA's current processes and systems for adverse event reporting vary across its centers and are not optimal for the efficient collection of voluntary and mandatory adverse event reports, product problems/consumer complaints, or errors associated with the use of FDA-regulated products. Current FDA reporting forms (Forms FDA 3500, 3500A, 1932, and 1932a) are an outgrowth of a paper process era and frequently result in the submission of inconsistent and poor quality information. In addition, the agency is limited in its ability to modify its paper forms to keep pace with changes in the types of regulated products and the information necessary to meet evolving standards to ensure post market safety. Further, the existing supporting business processes are not able to efficiently manage the information being provided on the paper forms.

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

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 56847	09/14/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 3433	01/16/2013
Did the Agency receive public comments on this ICR? No

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden estimate for the subject ICR was inadvertently over-reported in ICRAS/ROCIS in 2010, when the second and third rational questionnaires were approved as a non-material/non-substantive change. The over-reporting was caused by erroneously doubling the number of ICs from 6 to 12. This error was corrected by removing the 6 duplicative ICs. To further refine the reporting burden, 3 of the previous ICs that were segregated on the basis of mandatory versus voluntary reporting have been consolidated into one as appropriate. As submitted, the subject ICR now reflects a total of 4 information collections and also incorporates the burden reflected and approved under OMB Control No. 0910-0709. The latter ICR was initially obtained in May of last year to allow FDA to implement provisions of the Food Safety and Modernization Act. Accordingly, because of this consolidation, the Agency has submitted a discontinuation request for OMB Control No. 0910-0709 as it is now included in the instant ICR.

Annual Cost to Federal Government: $28,401,010

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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