As requested by
the agency, in addition to the approval of the revised forms, the
existing forms are approved for continued use for the next 6 months
to allow for the industry to make necessary changes to their
computerized systems. FDA shall continue to work with the regulated
community to simplify reporting to the extent possible, and work
closely with interested parties to incorporate public comment on
any efforts to change the reporting requirements prior to OMB
submission.
Inventory as of this Action
Requested
Previously Approved
03/31/2005
03/31/2005
09/30/2003
372,987
0
332,414
356,369
0
332,414
0
0
0
Reporting of adverse events and
product problems by health professionals to the FDA either directly
or via the manufacturer is critical to an effective national
postmarketing surveillance system. The overall MedWatch program is
a national educational/ promotional initiative designed both to
educate all health professionals about the critical importance of
being aware of, monitoring for, and reporting adverse events and
problems to FDA and/or the manufacturer, and to ensure that new
medical product safety information is communicated rapidly to the
health professional community, thereby improving patient
care....
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.
MedWatch: The FDA Medical Products Reporting Program