In accordance with 5 CFR 1320, the information collection request is approved for three years. However, OMBÂs action is currently limited to approval of the information collections associated with the Food Registry. We are providing placeholders of one hour that reflect OMB agreement that the planned development of the MedWatch system is consistent with the PRA. As the agency develops the other components of the MedWatch system and the specific instruments described in this request, they should consult with OMB, prior to implementation of new modules or revisions to the Food Registry modules, to determine whether further public notice is needed and/or the developments represent non-material/non-substantive changes.
On or before the next request for an extension of OMB approval, FDA should also consider whether the usability of the system for voluntary reports from consumers and other entities that may not be familiar with FDA terminology can be improved to reduce burden and improve the utility of the information received by FDA. FDA should also consider improvements or revisions to the voluntary components of this collection that more clearly indicate to the respondent when their response is not mandatory.
Finally, FDA is reminded that all information collections including those on websites, must display an OMB number and must provide the public with the information required in 5 CFR 1320.
Inventory as of this Action
Requested
Previously Approved
09/30/2012
36 Months From Approved
682,521
0
0
1,444
0
0
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.
FDA is implementing this new information collection in order to receive electronic data to improve adverse event reporting across the agency.
$12,967,899
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto 3018274659
No
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.
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