In accordance
with 5 CFR 1320, the information collection request is approved for
three years. However, OMBs 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