Medical Device Recall Authority

ICR 201202-0910-004

OMB: 0910-0432

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-05-16
ICR Details
0910-0432 201202-0910-004
Historical Active 200902-0910-003
HHS/FDA
Medical Device Recall Authority
Extension without change of a currently approved collection   No
Regular
Approved with change 06/12/2012
Retrieve Notice of Action (NOA) 02/13/2012
  Inventory as of this Action Requested Previously Approved
06/30/2015 36 Months From Approved 06/30/2012
48 0 2
1,090 0 1,090
0 0 0

This information collection includes the reporting, recordkeeping, and third-party notification requirements associated with the FDA regulations on medical device recalls.

US Code: 21 USC 360h Name of Law: null
  
None

Not associated with rulemaking

  76 FR 71041 11/16/2011
77 FR 7165 02/10/2012
No

  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 48 2 0 0 46 0
Annual Time Burden (Hours) 1,090 1,090 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$186,000
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  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.
02/13/2012


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