Administrative Detention and Banned Medical Devices

ICR 201604-0910-003

OMB: 0910-0114

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-04-11
IC Document Collections
IC ID
Document
Title
Status
5721
Modified
ICR Details
0910-0114 201604-0910-003
Historical Active 201302-0910-002
HHS/FDA CDRH
Administrative Detention and Banned Medical Devices
Extension without change of a currently approved collection   No
Regular
Approved without change 08/01/2016
Retrieve Notice of Action (NOA) 04/11/2016
  Inventory as of this Action Requested Previously Approved
08/31/2019 36 Months From Approved 07/31/2016
28 0 28
461 0 461
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 adulturated 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 authorities there are requirements pertaining to reporting and recordkeeping activities that are necessary in order for the Agency to carry out its mission to protect the public health.

US Code: 21 USC 334(g) Name of Law: FFDCA
  
None

Not associated with rulemaking

  80 FR 63232 10/19/2015
81 FR 21354 04/11/2016
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 28 28 0 0 0 0
Annual Time Burden (Hours) 461 461 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$41,149
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
04/11/2016


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