MEDICAL DEVICE RECALL COST SURVEY

ICR 199307-0910-004

OMB: 0910-0293

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
109999
Migrated
ICR Details
0910-0293 199307-0910-004
Historical Active
HHS/FDA
MEDICAL DEVICE RECALL COST SURVEY
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 10/20/1993
Retrieve Notice of Action (NOA) 07/19/1993
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

None
None


No

1
IC Title Form No. Form Name
MEDICAL DEVICE RECALL COST SURVEY

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 264 0 0 264 0 0
Annual Time Burden (Hours) 178 0 0 178 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
07/19/1993


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