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
01/31/2013
36 Months From Approved
04/30/2013
1,365,042
0
1,365,042
462,318
0
462,318
0
0
0
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.
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.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form 3800 Voluntary Adverse Event Report via the SRP
0645 SS 2013 .doc
Early Warning Recall Voluntary