Administrative Detention and Banned Medical Devices

ICR 200007-0910-002

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
5720
Migrated
ICR Details
0910-0114 200007-0910-002
Historical Active 199809-0910-013
HHS/FDA
Administrative Detention and Banned Medical Devices
Extension without change of a currently approved collection   No
Regular
Approved without change 08/10/2000
Retrieve Notice of Action (NOA) 07/07/2000
  Inventory as of this Action Requested Previously Approved
08/31/2003 08/31/2003 09/30/2000
26 0 2
461 0 69
0 0 0

The FDA has the statutory authority under section 304(g) of the FD&C Act to detain devices during establishment inspections which are believed to be adulterated or misbranded. On March 9, 1979, FDA issued a final regulation on Administrative Detention Procedures which includes, among other things, certain reporting and recordkeeping requirements. FDA also has the statutory authority under section 516 of the Act to ban devices that present substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct and substantial danger to the health of individuals. Under these....

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 26 2 0 0 24 0
Annual Time Burden (Hours) 461 69 0 0 392 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
07/07/2000


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