This information
collection request is approved under the following conditions: 1)
Consistent with the Oct. 20, 1993 letter from ERG Inc. to FDA, the
expensive recalls (>$25 M) will not be excluded, but studi
separately; 2) Any finding from the two studies must be presented
in combination; and, 3) To combine these two studies FDA must have
a full understanding of the frequency and distribution of both sets
of recall If FDA cannot obtain adequate information on the
frequency and distri- bution, the limitations of the findings will
be noted whenever the results are reported.
Inventory as of this Action
Requested
Previously Approved
12/31/1993
12/31/1993
264
0
0
178
0
0
0
0
0
TO ASSESS INDUSTRY BENEFITS FROM FDA
REGULATIONS ASSOCIATED WITH THE SAFE MEDICAL DEVICES ACT, THE COST
OF MEDICAL DEVICE PRODUCT RECALLS I NEEDED. A RANDOM SURVEY OF
DEVICE MANUFACTURERS THAT HAVE RECENTLY CONDUCTED PRODUCT RECALLS
WILL PROVIDE QUATITATIVE INFORMATION ON THES COSTS AND ALLOW FDA TO
CALCULATE THESE BENEFITS PURSUANT TO E.O. 12291
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.