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.
Form FDA 1932a Early Warning Recall Voluntary View
0645 83-c.doc
Early Warning Recall Voluntary