OMB approves
FDA's use of Emergency Health Surveys for 1 year to enable FDA to
quickly obtain targeted information on potential medical device
problems. The information gathered will be based on purposeful
samples and therefore can not be used for estimates of incidents.
Instead, the information gathered should be used to trigger a more
complete analysis of the problem, and a determination of the extent
of a public health problem. As a condition of clearance, FDA will
(1) submit a copy of the complete survey along with a justification
describing the need for the survey, (2) provide a complete
description of the statistical methods to be employed, including
the respondent universe and sample selection method, the
information collection procedures, and the expected response rate,
(3) an estimate of the burden. OMB will review the survey and the
accompanying justification in 10 working days or less. At the time
of the next submission, FDA and OMB shall evaluate the process used
under this generic clearance and determine how well it has worked
and whether any changes are necessary.
Inventory as of this Action
Requested
Previously Approved
03/31/2002
03/31/2002
2,000
0
0
4,000
0
0
0
0
0
This program will provide data when
FDA must quickly determine whether or not a post-market problem
with a medical device impacts the public health. The data collectrd
will provide FDA with information to: alow a more complete analysis
of the problem; determine the existence and extent of a public
health problem; and then, if necessary, to disseminate the
information to the health care community. All of these processes
must be accomplished in a timeframe that limits further incidents
causing injury to the public. While the form for data collection
will be standardized, the targeted respondent........
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.
Emergency Health Surveys