ADMINISTRATIVE DETENTION AND BANNED MEDICAL DEVICES

ICR 199209-0910-001

OMB: 0910-0114

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
109615
Migrated
ICR Details
0910-0114 199209-0910-001
Historical Active 198809-0910-001
HHS/FDA
ADMINISTRATIVE DETENTION AND BANNED MEDICAL DEVICES
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 11/05/1992
Retrieve Notice of Action (NOA) 09/02/1992
  Inventory as of this Action Requested Previously Approved
11/30/1995 11/30/1995
1 0 0
108 0 0
0 0 0

ADMINISTRATIVE DETENTION IS AN IMMEDIATE ACTION TAKEN TO PREVENT AN ADULTERATED OR MISBRANDED DEVICE FROM REACHING THE CONSUMER. FDA WILL BAN A DEVICE ONCE A DETERMINATION HAS BEEN MADE THAT IT PRESENTS A SUBSTANTIAL DECEPTION OR AN UNREASONABLE RISK OF ILLNESS OR INJURY.

None
None


No

1
IC Title Form No. Form Name
ADMINISTRATIVE DETENTION AND BANNED MEDICAL DEVICES

  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 1 0 0 1 0 0
Annual Time Burden (Hours) 108 0 0 108 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.
09/02/1992


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