Applications for Exemption from Preemption of Medical Device Requirements

ICR 199705-0910-003

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 199705-0910-003
Historical Active 199611-0910-003
HHS/FDA
Applications for Exemption from Preemption of Medical Device Requirements
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 07/21/1997
Retrieve Notice of Action (NOA) 05/23/1997
FDA will explore ways to reduce the per-request burden of this collection, and report on or implement such measures as part of the next request for clearance.
  Inventory as of this Action Requested Previously Approved
07/31/2000 07/31/2000
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.
05/23/1997


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