View ICR - OIRA Conclusion



0910-0645 200906-0910-003
Historical Active
HHS/FDA
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
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 09/03/2009
Retrieve Notice of Action (NOA) 06/19/2009
In accordance with 5 CFR 1320, the information collection request is approved for three years. However, OMB’s 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