Applications for Exemption from Preemption of Medical Device Requirements

ICR 199611-0910-003

OMB: 0910-0129

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0129 199611-0910-003
Historical Active 199212-0910-001
HHS/FDA
Applications for Exemption from Preemption of Medical Device Requirements
Reinstatement without change of a previously approved collection   No
Emergency 11/25/1996
Approved without change 11/26/1996
Retrieve Notice of Action (NOA) 11/20/1996
OMB approves this collection with the understanding that FDA will follow through with the standard PRA approval process, seeking public comment and eventually re-submitting it to OMB for review.
  Inventory as of this Action Requested Previously Approved
03/31/1997 03/31/1997
3 0 0
330 0 0
0 0 0

The regulation establishes procedures for State and local governments to apply for exemption from preemption for their preempted medical device requirements.

None
None


No

1
IC Title Form No. Form Name
Applications for Exemption from Preemption of Medical Device Requirements

  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 3 0 0 3 0 0
Annual Time Burden (Hours) 330 0 0 330 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.
11/20/1996


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