This submission
is withdrawn to correct a technical error in the collection. The
agency will resubmit within 1 business day.
Inventory as of this Action
Requested
Previously Approved
12/31/2011
36 Months From Approved
06/30/2012
636,116
0
636,116
682,483
0
682,483
0
0
0
To ensure the safety, and identify any
risks, harms, or other dangers to health, for all FDA-regulated
human healthcare products, the Agency needs to be informed whenever
an adverse event, product quality problem or product use error
occurs. This risk identification process is the first necessary
step that allows the agency to gather the information necessary to
be able to evaluate the risk associated with the product, and take
whatever action is necessary to mitigate or eliminate the public's
exposure to the risk.
FDA is requesting a renewal
with both a program change and minor adjustments in the existing
Forms FDA 3500 and 3500A. The program change is a result of an
Agency intention and goal of improving the number and quality of
voluntary reports from consumers of serious adverse events and
product quality problems by introducing a consumer-friendly version
of the existing From FDA 3500. The Agency estimates that the hour
burden with use of a consumer version of the existing voluntary
reporting form can be reduced based on informal testing of the
final, proposed version of the form, from the current 36 minutes
per report to 25 minutes, a reduction of 30%. It is estimated that
in CY2011, 35% of the 40,000 direct, voluntary reports submitted
using the Form FDA 3500 will be from consumers/patients. The
reduction in reporting burden hours for that population of
voluntary consumer-reporters would be 14,000 reporters x 0.183
hours, or a total annual burden-hour reduction of 2,562 hours. The
existing Forms FDA 3500 and 3500A have proposed minor changes to
each form, with no additional questions added and several questions
omitted as redundant information that is able to be addressed in
other questions. Several fields have had the label or title
modified in response to a change in law, rule or regulation or to
clarify the type of information to be entered in a given field. The
agency estimates that these changes will have no substantial impact
on either reporting burden-hours or costs.
$8,831,000
No
No
No
No
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.